A variety of different architectures are now available for modern LIMS, and these different architectures determine the way LIMS are installed, managed and utilized. Key factors to consider when selecting a LIMS is the type of architecture that is best aligned with your business goals, as well as the standards your organization’s IT group has established for IT architecture.

Until fairly recently, most LIMS software was licensed from the vendor and installed directly in the lab server/computers in what is known as an on-premise deployment. In recent years, several vendors have begun to offer LIMS deployment compatible with external hosting, offering full application functionality accessed through a device’s web browser and hosted at a third-party data center. In addition, there are now fully external “LIMS-as-a-service” offerings.

Each of the different architectures supported by commercial LIMS today has its own benefits and drawbacks. In this blog, we will present a few of the most common LIMS architectures that are utilized and discuss some of the benefits and drawbacks of each.

On-premise Deployment

Traditionally, LIMS software has been purchased from a vendor and the server and database installed (either with a physical CD/DVD or downloading through a web link) directly on internally owned and deployed computers with a fixed licensing fee. An annual maintenance fee is usually included in the initial purchase as well. This on-premise deployment architecture can be used with a thick client, where the user interface is also installed directly on an internally owned computer. Many modern LIMS leverage web services to render the user interface in a web browser, requiring no installation of LIMS software directly on user computers. This architecture is called a thin client.

Once installed, on-premise LIMS software, including database, server, and client installations, requires ongoing monitoring and maintenance from the company’s IT department. This type of architecture is useful for large companies or government agencies that require strict internal control of the systems because of high data security or other reasons and hence prefer to keep data behind the company firewall. With this architecture, however, skilled IT teams are necessary to operate, administer, maintain, and upgrade the system and infrastructure over its full lifetime.

Advantages:

• Functionality – thick client LIMS sometimes offer richer functionality compared to thin clients, and on-premise installed LIMS typically can offer higher performance.
• Data Security – on-premise installation allows for higher level of data security with tighter control over all the system components.
• Customization – on-premise installation can allow for higher degrees of customization and integration.

Disadvantages:

• IT Resources – requires a skilled IT team for system administration, maintenance, implementation, upgrades, patches, data backup, disaster recovery, etc. Implementation and upgrade processes can be complex and the ongoing expense of system patch management for security is required.
• Capital expense – typically larger initial capital expense for infrastructure requirements, license(s) and labor for implementation.

Managed Hosting Deployment

In this deployment architecture, the customer generally purchases the software from the LIMS hosting vendor in the same manner as with an on-premise deployment (license, annual maintenance fee, etc.), but the system is installed at a third-party hosting/data center. The customer stills owns and configures, and can customize, the software. The hosting vendor generally treats each customer separately and provides system-level support of the machines necessary for the database and application servers.

This deployment architecture can be used with either thick or thin clients, although successful use with thick client installations on the customer systems is very dependent on the network connectivity between the customer and the external data center. A variation of this is to use a remote desktop solution such as Citrix to support the installation of the thick client on servers managed by the external data center. In this variation, all the systems required to run the system are managed by the external data center.

Advantages:

• Functionality – offers the same functionality as the on-premise deployment.
• Fewer IT Resources – using the external data center resources reduces the customer IT resource requirements and the external data center can offer more sophisticated system management capabilities that might provide for deeper levels of system monitoring and improved backup and disaster recovery abilities. Customer IT resources are still required for system administration, installation, configuration and user support.
• Lower Capital Investment – the external data center operator bears the cost of the systems and infrastructure required to run the system.

Disadvantages:

• Data Security – the system’s data is under control of the external data center and their processes for backup and security must be carefully reviewed and managed.
• Network Dependency – you lose access to the system if your office loses the network connection to the external data center, and performance of the system will be dependent on this connection as well.
• System Integrations – integrating your LIMS with other enterprise or laboratory systems is potentially more difficult, dependent on the network architecture of the external data center.

Cloud Hosted Fully Managed Deployment (SaaS)

While in an on-premise and managed hosting system the customer owns the software, a SaaS (software as a service) LIMS hosting is typically licensed based on the demand (e.g., the number of users) on a monthly or annual basis. Typically, the SaaS model allows customers to flex the licensing based on only the use of software they require, as opposed to the more fixed traditional set license fees, although discounts are also generally offered based on customer commitments to users and/or time.

With a SaaS LIMS hosting , the management of the software application and infrastructure is the responsibility of the SaaS vendor. Typically, many different users (customers) run on a single instance of the software and database in what is called a multi-tenant mode. Some SaaS vendors make their systems licensable in a single-tenant mode, where the customer has dedicated infrastructure for the application and/or the database. The single-tenant SaaS model offers additional data security, but usually at a substantially increased cost. In either SaaS model, the user does not have to maintain either the physical servers used or the cloud-based application, and the customer accesses the software application via a web browser.

Advantages:

• Pay-as-you-go – you only pay for what you use. On demand licensing enables LIMS to become a variable expense, rather than a large fixed cost at the time of purchase. This will also generally translate into a lower cost of entry.
• Least Required IT Resources – All of the administration and support of the underlying application infrastructure is the responsibility of the vendor. Customer IT resources may be required for application administration and/or configuration, but installation, system administration, backup, disaster recovery, etc. are all the responsibility of the SaaS vendor.
• Scalability – the elasticity and resource pooling aspects of the cloud allows for more rapid and flexible scalability with increased use.
• Reduced Deployment Time – since the application has been implemented in the cloud, your organization can be up and running on an SaaS LIMS very quickly.
• Reliability – The SaaS vendor is typically contractually responsible for system availability and communication of scheduled downtimes. Most SaaS vendors employ redundancy in their infrastructure and high-availability architectures to meet the contractual requirements.

Disadvantages:

• Integration– it can be difficult to integrate on-premise systems with a cloud-based application. Both the LIMS hosting vendor and customer will need to work together to make this happen.
• Customization – Most SaaS systems have very limited or no ability to be customized. Because the vendors business model is based on distributing the use of costly infrastructure across multiple customers, the software is generally only able to be configured in very specific ways. This may result in less functionality compared to the other options that provide you with more complete control over the system functionality.
• Cost – monthly fees can add up over time and end up being more than an on-premise solution. Also, there is no permanent access to the system in the same way as what you get with a perpetual license to on-premise installed software.
• Data Security– with a SaaS system, data travels and is stored outside your organization’s firewall. This means you are relying on the service provider for data security. Also, ultimate ownership of data in terms of future system migration and/or archival need to be explicitly structured and negotiated.
• Complexity of Validation – System validation is a potentially more complex activity, requiring both the SaaS vendor and the customer to closely cooperate. Upgrades may be more challenging in a multi-tenant environment if the vendor forces upgrade timelines.
• Limited Options – There are fewer LIMS systems on the market that are capable of being delivered as SaaS, offering less choice of vendors.
• Network Dependency – As with managed hosting, you lose access to the system if your office loses the network connection to the external data center, and performance of the system will be dependent on this connection as well.

Conclusion

A key factor to consider when choosing a LIMS is the deployment architecture. There are three fundamental options supported by commercial LIMS today: on-premise, managed hosting, and SaaS. Each has benefits and drawbacks, and in order to achieve an integrated laboratory environment providing a high level of business value for your organization, it is important to consider how these advantages and disadvantages align with your business goals and requirements.

Astrix is a laboratory informatics consulting firm that has been serving the scientific community since 1995. Our experienced professionals help implement innovative solutions that allow organizations to turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.

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This impacts various aspects of the process including the quality management, LIMS and MES solutions leveraged in these organizations. In this blog we discuss the unique requirements.

Quality Management System

With Cell Therapy manufacturing, quality management processes and procedures, supported by systems, should be established early to ensure a secure, documented lifecycle management for SOPs, work instructions and manufacturing documentation.

Processes for manufacturing incidents, non-conformance and deviations, corrective action, audits and preventative action, change control, risk and mitigation, and training and personnel qualification management all fall under the Quality Management System.

Quality Control LIMS

The typical cell therapy manufacturing process includes tens of ‘in process’ sampling points per batch as well as final product testing, and batch specific and general environmental monitoring and sampling.

QC testing of incoming materials also needs to be performed and documented. Initially sample and test result management may be handled manually on paper, however, it will rapidly require electronic systems support as the number of patients (and batches) grows. Many mature manufacturing QC LIMS and Environmental Monitoring (EM) commercial solutions exist that can address the needs in this area. However, it should be noted that EM operations and workflows are unique and usually require specific solutions complementary to standard LIMS solutions.

Manufacturing Execution System

Manufacturing shop floor needs have typically been accommodated via paper and manual processes through early clinical. Going forward, systems will be needed to offer more accurate modeling of the manufacturing process for different product lines along with resource (people, equipment, shop floor) requirements and execution times so that finite capacity planning can be performed. The resultant models are used to provide electronic detailed production schedules across product orders.

Warehouse management capabilities will be needed to support site specific receipt, storage, and subsequent kitting and batch record capture of issued materials (if not handled within the ERP solution).

Implementation of electronic batch records (EBR) may also be considered but should be assessed relative to the maturity of the manufacturing process. Some of the key benefits to EBR implementation include the ability to review by exception and the availability of electronic data for process development use. Modern EBR systems are certainly easier to adjust but the manufacturing process must be stable enough to warrant the time and effort that will be expended in development and particularly validation.

There are many commercial MES solutions in the marketplace. Most cover the range of capabilities described above. Many have a specific focus on pharmaceutical manufacturing with consulting resources who are familiar with the pharma domain. However, as noted earlier, cell therapy processes are somewhat unique, smaller scale, multiple batches, and employ limited process automation so some of the solution capabilities may not be directly applicable. The MES space has lacked in investment for a period, but there appears to be renewed interest in revamping the technologies. Flexibility to deal with changes and user interface usability should be high on the list of evaluation considerations.

Summary

Cell Therapy manufacturing requires unique system requirements relative to a QMS, LIMS, and MES. Processes for manufacturing incidents, non-conformance and deviations, corrective action, audits and preventative action, change control, risk and mitigation, and training and personnel qualification management all need to be considered.

Given the nature of Cell Therapy manufacturing, it requires tens of ‘in process’ sampling points per batch as well as final product testing, and batch specific and general environmental monitoring and sampling. Additionally, QC testing needs to be performed on incoming materials and documented.

There are also unique manufacturing execution system needs for Cell Therapy manufacturing as well as warehouse management needs and the potential utilization of electronic batch records.

Why It Matters to You

Given the personalized nature of cell therapies, the quality management aspect also entails a certain degree of special considerations. In this blog we discussed:

• The specific processes and unique requirements for a Quality Management System.
• What is needed relative to a Quality Control LIMS solution.
• The unique needs of a Manufacturing Execution System in this environment.

The post Cell Therapy Manufacturing and the Unique Requirements for a LIMS, QMS, and MES Solution appeared first on Astrix.

• delivered on time and within budget
• meets or exceeds all user requirements
• provides business value
• high-level of user adoption.

LIMS projects usually demand a substantial investment of time, money and resources, with implementations costing hundreds of thousands to millions of dollars and requiring hundreds of person days to implement. Failure of a LIMS project can be a huge waste of time and resources, and a financial disaster for the organization involved. As such, it is critical to get a LIMS implementation project right the first time in order to preserve your return on investment. In this blog, we will discuss the seven most common reasons why LIMS implementations fail.

Reasons for LIMS Implementation Failures

There are many reasons why laboratory informatics projects fail. Some of the more common ones include:

Lack of Strategic Planning Prior to LIMS Selection and Implementation

Not taking the time to fully understand your needs (both now and in the future) and develop proper requirements that reflect these needs is probably the most common cause of failure in LIMS implementation projects. Many times, companies simply purchase a LIMS based on reputation and rush to implement their current requirements into the system. The danger here is that you end up with a project that is too focused on time and/or cost at the expense of value. This approach represents a missed opportunity to understand and optimize underlying workflow process that will maximize the business value of the implementation.

Conducting a thorough workflow analysis is essential to develop optimized future-state system requirements that will guide the LIMS selection and implementation and thus ensure your project will produce significant business value for your organization. In addition, the effort (and thus cost) that is required to implement and ultimately maintain the LIMS will be significantly influenced by the quality and clarity of the requirements that are generated and implemented into the system.

Another aspect of strategic planning that is important for the success of many LIMS implementation/integration projects involves the laboratory informatics architecture. Designing a practical enterprise architecture for the laboratory, along with a roadmap to deployment, is essential for any LIMS implementations that involve integration with instruments, parallel and adjacent systems. Having an overall strategic vision for the laboratory informatics ecosystem helps to ensure that the LIMS implementation maximizes business value for your organization and stays within time and budget constraints.

Personnel Resource Challenges

Staffing requirements for a LIMS project can be extremely complex. Wide-ranging knowledge about the different systems available on the market is important to ensure you select the best LIMS for your organization. Additionally, a variety of different skill sets are necessary to accomplish the strategic planning, configuration, integration and validation required to successfully execute a LIMS implementation project. Unforeseen project challenges can also require outside specialists and/or subject matter experts to move the project forward.

Another issue is that there are multiple roles that need to be staffed with internal personnel, and the time commitment required for project duties often means these people cannot continue with the full responsibilities of their day jobs. This can mean that backfilling a number of positions in the lab for the duration of the project may be necessary.

The bottom line is that you need to have a highly competent and skilled project team in place to ensure project success. Several key roles on the project team will likely need to be staffed by the LIMS vendor and/or an external consultant.

Poor Project Management/Governance

A key factor for a successful LIMS implementation is a dedicated project manager (PM) with LIMS experience who is involved in both the planning and ongoing management of the effort. Strong project controls and governance are needed to implement a LIMS successfully, and a LIMS-experienced PM will help to drive triple constraints (on time, on scope and on budget), ensure value realization and help to avoid common people-based challenges.

A formal risk management and mitigation plan should be developed in advance, which should include ongoing reviews of project phases throughout implementation that involve all inside and outside resources. A combination of project management skills, good resources (both internal and external), and methodologies are vital to a successful LIMS implementation.

Poor Communication

Clear and frequent communication between stakeholders is critical to the success of a LIMS implementation. It is vitally important to create and implement a comprehensive project communication plan as part of your LIMS project governance model. The communication plan helps convey critical information necessary to keep the project on track, and also engages all stakeholders so they feel part of the process.

The person or people facilitating communications between stakeholders plays a key role in the communication plan. Different aspects of organizations often speak “different languages” and may have trouble communicating with each other effectively (e.g., IT and lab personnel). It is important to have someone who is well-versed in all the different stakeholder domains facilitating communications in order to avoid misunderstandings.

Excessive Customization

The requirements developed in the workflow analysis conducted at the beginning of the project should be prioritized and implemented in an iterative approach with the “must haves” implemented first as described above. Failure to follow this kind of methodical approach can cause the project to get bogged down in excessive customization to satisfy lower value requirements, leading to project time delays and cost overruns. Unnecessary customization can also occur if there is not at least one person on the project team who is aware of all the configurable functionality available in the LIMS being implemented.

Customization increases the complexity of future maintenance, migration and validation efforts, and can potentially lead to system errors. The bottom line is that LIMS customization should only be done if doing so would provide your organization significant business value or a competitive advantage.

Inadequate Planning for Master Data Management/Migration

Data management/migration is almost always a bigger job than anticipated during a LIMS implementation. Many companies tend to focus on software testing and configuration and put off dealing with master data management or data migration until late in the implementation process, but this can end up causing significant project delays in addition to impacting business continuity in the lab.

For this reason, it is wise to focus on data migration early in the implementation process. Static legacy data (and sometimes dynamic data as well) must be extracted, translated (biggest effort) and loaded into a new location. The actual migration is typically accomplished through a combination of automated programmable migration tools and manual processes. Dynamic data migration should be done last to make sure the new system contains the most up-to-date data.

Conclusion

As discussed in this article, proper planning, adequate financial and personnel resources, and a proven methodology is vital to the success of LIMS implementation projects. There are in fact several other factors that are equally critical to consider in order to ensure project success.

The post Commmon Causes of LIMS Implementation Failures appeared first on Astrix.

Core LIMS provides a wide array of highly configurable functionality to meet the needs of the customer including:

• Lab Inventory and Storage Management
• Lab Project Management
• Electronic Document Management
• Instrument Integration and Management
• Integration with Other Systems
• Chemistry and Cheminformatics
• Molecular Biology, Cell Culture and Bioinformatics
• High Throughput Screening (HTS)
• Animal Study Management
• Animal Facility Management
• Customized Reporting
• Workflow Management and SOP Enforcement
• Study Management
• User Security
• Environmental Monitoring
• And more

With Core LIMS flexible, component-based architecture (including database and infrastructure services), organizations have the ability to purchase the functionality required to support their present data management requirements, without the need for much custom coding or having to pay for any unnecessary services. As needs change, additional components can be purchased to meet expanded requirements. Additionally, the PFS approach for Core LIMS dramatically reduces the time and resources necessary to configure and implement the LIMS, and also ensures that your system will be stable, extensible and user-friendly.

While Core LIMS offers the potential for significant operational and business benefits for your organization, there are a number of best practices that are highly recommended when implementing or upgrading the Core LIMS solution in order to realize its full potential to optimize your laboratory operations. In this blog, we’ll discuss several recommendations that are important to follow during your Core LIMS implementation or upgrade that will help ensure that your project goes smoothly and that you get the most from your investment.

Tips for Optimizing Core LIMS Implementations and Upgrades

Use the API

One of the most powerful features of the Core LIMS is its API (Application Programming Interface). Almost every action that a user can perform through the interface can also be handled with an API call. This makes it possible to integrate the LIMS with your existing systems and tailor the interface for your specific needs.  Because the API uses the industry-standard Javascript language and REST protocol, there is a reduced need to get involved with vendor-specific scripting languages. Astrix team members have integrated the Core LIMS platform with multiple 3^rd party databases, CRM systems and project management systems.

Understand the Core Data Model

The Core LIMS Data Model is very flexible, but it requires some experience to get the best out of it. Understanding how Assays, Experiments, Samples and Custom Entities fit together is crucial in building a scalable, extensible platform. You will want a team that has experience working with scientists and other Subject Matter Experts, who are able to translate scientific requirements into the workflow and language of Core LIMS. Astrix team members are veterans of multiple implementations, and can provide your team with best practices and lessons learned.

Plan Before You Build

Many aspects of your Core LIMS installation can be changed after you implement, but other decisions are more or less final. It’s important to understand which decisions you make at the beginning of the project will be with you for the duration of the project, and make the right decision at the beginning. Towards this end, it is imperative that all stakeholders understand the decisions that are being made, and why they are being made, before anything is configured.

Create Good Documentation

For regulatory and future maintenance requirements, the owners of the Core LIMS system need to document all the relevant changes to the system after the project ends – database fields created, code created or modified, integrations and interfaces, workflows configured, etc. Working with a quality external informatics consultant makes this easy, as they will provide the documentation for you. Documentation provided by Astrix on Core LIMS projects includes:

• Project Plan – responsibilities, communication plan, work schedule, etc.
• Requirements Traceability Matrix – requirements description, categorization (standard/configuration/customization), design ideas, prioritization.
• Functional/Design Specification – relevant technical changes to the system and/or system architecture.
• Testing Documentation – IQ/OQ/PQ scripts or protocols for validation (required for regulated laboratories).

Stay on top of New Developments

The Core platform is evolving relatively quickly, and new versions bring new capabilities.  You’ll want to keep an eye on the road ahead to determine if the functionality you need is coming in a later release, or whether you should build it now on your existing installation.  Astrix maintains a strong partnership with the Core LIMS business and development teams, so we can provide the most up-to-date information on the future direction of the Core platform.

Think about Security Early

Core LIMS has a multi-layered security framework built into the system. To fully utilize this feature, it is important to detail the desired user roles and the permissions associated with each role before you build the system. Designing and implementing user permission layers often turns out to be a bigger task than expected. Waiting until the end of the project to implement a security framework is a recipe for cost and time overruns.

The Astrix Difference

The Astrix Team brings together the technical, strategic and content knowledge necessary to effectively implement and integrate Core LIMS into your organization. Our team has proven expertise in project management, implementation, integration, validation and system optimization for Core LIMS. Our accomplished consultants also have a wealth of experience across various organization types, helping to ensure that business-specific needs, along with industry and regulatory requirements, are taken into consideration on your project.

As your laboratory needs evolve due to regulatory or business changes, it is often necessary to begin to utilize new features of Core LIMS, or upgrade to a new version that has the functionality to fulfill your changing requirements. Whether you need to implement Core LIMS as a new system, optimize or adjust your current implementation, or upgrade to a new version, Astrix can help ensure that any new configuration or customization of Core LIMS is accomplished in the most efficient, cost-effective and timely way that satisfies your present and future requirements and budget.

Let us help you with:

• Strategic planning to make sure that your implementation/upgrade project satisfies production, operational and financial goals.
• Cconfiguration and/or customization
• Instrument integration with Core LIMS
• Computer system (e.g., laboratory, business and manufacturing system) integration with Core LIMS
• Data migration from legacy systems
• Training for key personnel
• Core LIMS validation services
• Scientific and Technical Staffing Services to backfill laboratory staff so that your Core LIMS project does not disrupt operations.

Conclusion

Core LIMS provides a wide array of highly configurable functionality that allows customers to manage data across its full lifecycle in the 100% web- and cloud-based Platform for Science. The cloud-based nature of the solution allows for complete scalability, multi-site support, and 24-hour and remote access. While the potential for this system to help increase productivity, efficiency and innovation in your laboratory environment is great, it is important to work with a quality laboratory informatics consultant who has the necessary experience and expertise with the software in order to realize its full potential.

The post Tips for Implementing or Upgrading Core LIMS appeared first on Astrix.

Organizations often struggle to adequately resource a LIMS deployment from the planning stages all the way through to delivery utilizing only internal resources. It is challenging to identify personnel within the existing teams that meet all of the necessary qualifications and have the bandwidth for dedicated LIMS program management in a fluid role with their daily ongoing responsibilities, ultimately putting the project at risk.

Investing in the Success of your LIMS Project

A Harvard Business Review (HBR) of the risks inherent in IT projects when not managed properly cited:

• 1 in 6 projects will experience a 200% budget overrun and a schedule overrun of 70%.
• 55% of project managers cited budget overrun as a reason for their project failure.
• The average budget overrun is approximately 27%.
• Frequently, only 25 to 50% of the projected benefits are realized at the end of the project.

The Project Management Institute (PMI) reports that organizations that invest in proven project management practices waste 28 times less money because more of their strategic initiatives are completed successfully.

Resourcing your LIMS Program Management Team

Choosing the right LIMS PM from the outset of the project will not only save your organization money by keeping the project on budget but will also help you to avoid the statistically significant failure points outlined above that cause projects to fall short of expectation or fail entirely.

Partnering with a trusted informatics consultant to fulfill your program management needs will ensure that you have the proper qualifications, expertise and resource commitment that is critical to the successful deployment of your LIMS. External consultants can provide a more holistic approach that is highly aligned to your organizational strategy due to their broader level of experience and expertise to deliver optimum results over the full lifecycle of the project and maximize the benefits that you will gain from your LIMS implementation.

Why it Matters to You

A LIMS implementation can be a complex process to navigate and align with the business goals of your organization while tailoring the functionality to your unique laboratory environment. Getting this done right the first time is critical to the long term success of your operations and requires effective and efficient management throughout the project lifecycle.

• Utilizing a qualified program manager from the outset of your project all the way through execution can dramatically improve the benefits you will receive from the project and will ensure that the project is delivered on time and within budget.

• Partnering with an experienced informatics consultant can provide the program management expertise needed to deliver added value and the best possible results for your LIMS deployment.

• Choosing the right LIMS program manager will not only save your organization money by keeping the project on budget but will also help you to avoid the statistically significant failure points outlined above that cause projects to fall short of expectation or fail entirely.

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation & dedicated staffing services for science-based businesses. Through our proven laboratory informatics, digital quality & compliance, and scientific staffing services we deliver the highly specialized people, processes, and technology to fundamentally transform how science-based businesses operate. Astrix was founded by scientists to solve the unique challenges which science-based businesses face in the laboratory and beyond. We’re dedicated to helping our clients speed & improve scientific outcom

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With dozens of LIMS vendors now available to choose from, and in increase in specialization in terms of targeted laboratories and increasing demands for cloud-based applications, selecting the best LIMS has become more difficult than ever. In fact, these days there really is no such thing as “the best LIMS.” The focus instead should be on selecting the LIMS that is best for your unique laboratory and organization. In this blog, we will discuss some of the important variables you will need to consider in determining which LIMS will provide the most business value for your organization.

Factors to Consider When Selecting a LIMS

Selecting the best LIMS for your laboratory and overall organization depends on a wide variety of factors that define your business needs. Some of these factors include:

Your Industry. The industry that your lab is operating in is an important factor to consider when choosing the best LIMS for your organization. There are now wide varieties of specialized LIMS on the market that have been designed to support particular industries. LIMS designed to support pharmaceutical industry QC labs, for example, will have a myriad of features to support regulatory compliance – e-signature support, chain of custody, standards and reagents tracking, audit trails, instrument calibration/maintenance, etc. On the other hand, LIMS that are designed for unregulated industries, while having some of the above features, will also have features designed for workflows specific to that industry.

There are also a variety of general purpose LIMS on the market that can be configured to support just about any workflow and/or business need. An organization with a rapidly evolving business environment, and/or a well-established and experienced IT department, may be better served by evaluating a general purpose LIMS rather than a specialized system, due to the ability to make frequent changes to the system via configuration/customization.

Your Lab Type. Are you running a QA/QC lab that supports manufacturing, an analytical lab that supports research, or an early stage R&D lab? The answer to this question may determine the kind of LIMS that will best support your laboratory environment. In addition to targeted LIMS supporting specific industries, there are specialty LIMS that cater to different types of labs within a particular industry. These LIMS have functionality that is tailored to a specific type of laboratory. For example, LIMS that are designed for an analytical lab may be configured to provide a portal allowing researchers at various sites to easily submit samples to your lab for testing.

Your Need for Flexibility in the Platform. While most LIMS have similar functions and capabilities available, different solutions can vary widely as to how the functionality and capabilities are provided and configured.  Some LIMS present a wide array of out-of-the-box (OOB) functions and features already incorporated into the product (i.e., standard) and ready to use upon installation, while others have those features available through configuration via the tools provided by the system.

Most organizations will find an OOB, feature-rich LIMS to be the most appealing option, as it may be easier to implement with a lower total cost of ownership (TCO). Yet, for some organizations with unique needs, a strong IT department and/or a rapidly evolving business environment, may find the flexibility and control inherent in the more customizable/programmable LIMS as a more appropriate choice.

Your IT Architecture. A key factor to consider when choosing a LIMS are the standards your organization’s IT group have established for IT architecture. There are a variety of architectures supported by commercial LIMS today (thin client, thick client, cloud-based), each with their own benefits and drawbacks.

If, for example, your organization has a strong IT department and has made the decision to keep applications within its firewall for security purposes, selecting a SaaS cloud-based LIMS would probably not make sense. On the other hand, if your organization has chosen to reduce IT expenditures by primarily supporting cloud-based lab applications, a LIMS that can only function as a thick and/or thin client would be out of the question.

In order to achieve an integrated laboratory environment providing a high level of business value for your organization, it is important to design a laboratory informatics architecture aligned with business goals, along with a roadmap to deployment, before engaging in a technology selection process for your organization.

Your IT Resources. The LIMS resources your organization has available to implement and support your chosen system will be an important factor in determining which LIMS to select. The resources required to successfully implement and support a thick client LIMS, for example, are extensive. Organizations lacking a strong IT department will likely want to select one of the following:

• A cloud-based system that requires minimal resources to install and maintain.
• A Commercial Off-The-Shelf (COTS) system with extensive functionality already configured.
• A specialty LIMS tailor-made to your industry and lab type, thereby requiring less configuration.

Your Cost Limitations. The TCO of the LIMS solution is invariably an important factor to contemplate when making your LIMS selection. A comprehensive analysis should be conducted, looking at as many factors affecting TCO as possible (e.g., LIMS licenses, standard functionality, extra costs of modules, customization required, annuity maintenance, etc.) for each system being considered. The TCO of a solution is part of what determines “the best” LIMS for your organization.

Conclusion                                                                                  

An effective technology selection process is a critical part of developing an efficient and well-integrated laboratory environment. Care must be taken to avoid purchasing systems not addressing specific business needs, or with features or add-ons that do not yield significant business value.

In this blog, we reviewed just a few of the important factors to consider when choosing the best LIMS for your organization. In our experience, successful laboratory informatics technology selection requires a comprehensive methodology in order to ensure that user adoption of the new system is high, and business value is maximized for your organization. This methodology should include a thorough workflow analysis to develop optimized functional requirements before the technology selection process is engaged.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.

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An estimated 75% of the total operational costs within a laboratory comes from the manpower needed to maintain its daily activities. Through the automation of manual and routine processes, these overhead costs and be significantly reduced. This can often be achieved by integrating and digitizing laboratory operations, managing samples and testing more efficiently, and streamlining the flow of information. One of the first elements on the path to laboratory efficiency is to get the LIMS implementation right the first time. A common pitfall in this effort is to quickly implement a LIMS solution without fully grasping the handoffs between groups and the associated interdependencies that can make or break the final result. So how can you set your organization up for success when implementing a LIMS?  Whether you are moving from a paper-based environment to a fully digitized laboratory environment, or embarking upon the replacement of a legacy platform, the principles described here will set on the path to achieving the desired outcomes of your LIMS implementation.

Principle #1:  Do understand the laboratory processes and key requirements

The first step in executing any laboratory informatics system is to gain a thorough understanding of the processes that comprise your entire laboratory operations. This is especially true for LIMS as they often serve as the operational backbone of the lab. A complete understanding of laboratory scientific and business processes is essential to selecting the right LIMS vendor and for planning the implementation. Once the laboratory processes are fully understood, the next steps are to define and prioritize key requirements. Because they are the basis for evaluating and selecting the LIMS platform and, ultimately, determining how much customization is needed, the requirements specification process should begin as early as possible.

Principle #2:  Don’t succumb to “analysis paralysis”

Prioritizing user requirements is equally important as defining them. There is so much information available during the evaluation phase of a LIMS implementation that it is easy to get lost in specifying lower-level, detailed processes, which can lead to “analysis paralysis.” Often when you are working with scientific end users, they want to be sure that every detail is correct. Though such details are important, it is critical to focus on the details at the right time, in the right order. A better strategy is to develop priorities based upon satisfying the immediate needs of the lab (i.e., the ones that affect current processes) followed by longer-term strategic objectives. Moreover, defining user requirements is not a one-time activity, resulting in a static set of requirements for vendor selection. Instead, it should be viewed as an ongoing process that can be refined on a regular basis to adapt to the changing needs of the organization.

Principle #3:  Do build the business case 

Though the justification for a LIMS solution may be obvious to the laboratory R&D staff, it is still critical to build the business case with a positive ROI. The bottom line is that facts are always harder to dispute than opinions. Building a comprehensive business case will help justify the acquisition of the LIMS, and a good one will present tangible business benefits based on defined requirements and key performance metrics.

Most organizations require a business case demonstrating a positive ROI before resources and funds are committed to a project. Depending on the scope and complexity of the project, most LIMS implementations will demand a business case that addresses the concerns and needs of all of the project’s stakeholders. A business case that anticipates potential problems or objections can also be a powerful tool to sell the project within the organization. Involving key stakeholders in the development of a business case can also be a strong way to build organizational support for the new system. A compelling business case will assess current system performance against expected post-implementation performance.

Principle #4:  Don’t assume that extensive customizations will be easy to sell to the organization

Establishing key performance indicators (KPI) allows quantifiable measurement of progress during implementation and ensures a tie to real changes in performance. These metrics can also be used to evaluate LIMS software vendors and select which software modules best suit the user requirements. The issue of whether customization is necessary to satisfy a new user requirement is often raised during the implementation process. A business case with a positive ROI allows the merits of customization to be considered on the same basis as the original implementation. Investments in customization can be evaluated according to whether they fit the requirements defined in the business case, based on performance metrics that are quantifiable, rather than subjective measures.

Principle #5:  Do ensure proper project management and resource commitment

Another characteristic that distinguishes best-in-class LIMS implementations is how well the implementation is managed. A prerequisite for a successful LIMS implementation is an experienced, dedicated project manager who is involved in both the planning and ongoing management of the effort. The company must also be willing to commit sufficient resources to the project before, during, and after implementation. Having the correct blend of internal and external resources will provide the balanced approach required for effectively managing your LIMS project. Augmenting your internal resources with an experienced team of external resources will provide a broader, holistic view of the key areas of focus and best practices for your LIMS implementation. This will also ensure proper project management and resource commitment throughout your project, including expertise with your platform of interest.

Strong project controls and governance are also needed to implement a LIMS. A formal risk management and mitigation plan must be developed in advance, which should include ongoing reviews of project phases throughout implementation, with full participation of all inside and outside resources. A combination of project management skills, resources, and methodologies are vital to a successful LIMS implementation.

Principle #6:  Don’t assume that you have sufficient executive and organizational commitment

A distinguishing trait of best-in-class LIMS implementations is that they have the full support and commitment of the company’s executives. In fact, it can be argued that this characteristic is the most important one for a successful LIMS implementation. Without this support, LIMS initiatives usually will not receive the funding and level of resourcing that is critical to the project’s success. LIMS initiatives often begin with the IT director or manager, but the support of the CIO, CFO, and other C-level executives is essential. The executive team is responsible for setting corporate business strategy and direction, so it is important that they are involved in the decision making process regarding how the LIMS system will be utilized across the key business areas.

Depending on the breadth of the system, LIMS implementations can also cause changes in the familiar workflows for people throughout the organization, whether they are directly involved in the implementation or not. For this reason, it is important to gain broad organizational support during all phases of a LIMS implementation. Finally, the establishment of regular project reviews with the executive team or the project steering committee will keep them informed about project progress. It will also provide a forum so that the appropriate decision makers can quickly be advised of any issues that may arise during the implementation process.

 Principle #7:  Do recognize the value of early planning

In any LIMS implementation, there is no substitute for careful planning; in fact, planning should begin during the earliest project phases. Diving directly into a LIMS implementation without a fully developed plan in place will generally not result in the desired outcomes within the timeframe and budget that is needed. The project plan should have time built into it for activities associated with requirements definition, key performance measures, and vendor evaluation and selection. The best plans have buffers built into the schedule to account for activities such as testing, data migration, and unforeseen events that occur in every implementation. Companies that invest in comprehensive, upfront planning often experience shorter implementation times and spend less money overall than their peers.

Principle #8:  Don’t save data migration for last!

Incorporate your data migration into the early phases of the implementation process. Many companies tend to focus on software testing and configuration and put off dealing with data migration until late in the implementation process. An attribute of successful LIMS implementations is that data migration is put into the project plan as early as possible. A company’s data is one of its primary assets and issues with migrating data between legacy systems and a new LIMS system can have a sizeable negative impact on laboratory operations, especially when those issues occur late in the LIMS implementation process.

Summary

Selecting and deploying a LIMS system within your organization can be a complex endeavor. Careful planning and proper resourcing is critical to the success of your LIMS implementation. An experienced, dedicated LIMS project manager will ensure that your LIMS project will deliver the expected results, in the specified timeframe and within budget.

Eight Key factors leading to a successful LIMS implementation and getting this right the first time include:

• Understanding the laboratory processes and key requirements
• Don’t succumb to “analysis paralysis”
• Building the business case
• Avoid extensive customizations
• Ensure proper project management and resource commitment
• Gain sufficient executive and organizational commitment
• Recognize the value of early planning
• Don’t save data migration for last!

About Astrix

 Astrix has been an industry leader for over 25 years in helping scientific organizations implement and integrate improved informatics systems in the laboratory. Our experienced team of expert informatics consultants bring together technical, strategic, regulatory and content knowledge to provide the most effective solutions to problems faced by scientific organizations. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey. Visit astrixinc.com for more information.

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IT projects are notorious for failure – a recent survey by cloud portfolio management provider Innotas revealed that over 50 percent of businesses surveyed had experienced an IT project failure within the previous 12 months. LIMS projects can be especially challenging, given the many different aspects of the enterprise that modern LIMS touch.

With the stakes being so high, how can you set your organization up for success from the beginning?  Let’s start by exploring the most common reasons why LIMS project fail in the first place.

LIMS Selection Implementation Failures

LIMS projects require large investments of money, resources and time – costing anywhere from hundreds of thousands to millions of dollars, and requiring hundreds of hours to implement. And while a successful LIMS implementation can help your organization streamline workflows, cut costs, improve quality and compliance, a poorly planned and implemented LIMS can be devastating to an organization.

There are a number of different metrics that can apply in the case of a failed LIMS project:

• Implemented without all of the required functionality
• Project did not meet the targeted goals and objectives
• Grossly missed timeline and budget
• Project was cancelled

Some of the most common reasons why LIMS projects fail are:

• Insufficient resources
• “Bloated” or misaligned scope
• Poor project management
• The wrong LIMS was selected for the organization

The last reason in particular is unfortunately quite common in our experience. Let’s explore the top five LIMS selection mistakes that organizations make in more detail.

LIMS Selection Mistakes

Mistake #1: Buying solely on a recommendation. Lab or IT managers will often purchase a LIMS based on a colleague or a friend within the company saying they “liked” a particular system, or that it is a “good” LIMS. The outcome of following these kind of qualitative assessments is that you end up buying something that works for your friend, but will likely not meet your specific requirements.

In order to avoid this issue, it is important to establish a LIMS evaluation process that is focused on your organization and its specific requirements. Towards this end, you should:

• Establish your goals and objective for the LIMS project
• Evaluate current laboratory processes
• Document your requirements
• Develop a LIMS evaluation plan
• Seek assistance from an outside contractor with LIMS expertise

Mistake #2: Beginning with insufficient budget. Companies often budget for their LIMS project before they have fully documented their requirements. This can lead to a situation where the project ends up being constrained by an arbitrary number that does not allow for goals and objectives to be met, with decisions centered around cost instead of requirements:

• the lowest cost system is selected
• the scope of the project is cut – testing and training are scaled back, for example
• the implementation effort gets placed in the lap of the lab manager and shadow IT

In order to avoid this mistake, companies should perform a business case analysis to set the budget for the LIMS project:

• Define goals and objectives
• Describe the project’s benefits to the organization
• Develop accurate costs – both external and internal
• Describe how the LIMS will drive value
• Utilize a Value Engineering approach – align with company KPI’s
• Seek assistance from an outside contractor who has the ability to help you integrate your LIMS project into business processes

Mistake #3: Dictate timeline to the vendor. Telling the vendor when the project must be complete leads companies to work backwards when developing the project plan, placing “artificial” dates on project tasks. This creates the perception that the project is failing, as the project team ends up trying to manage a contrived timeline that was not well thought out. Inevitably, this approach necessitates a project re-boot somewhere down the road, as the project team is forced to create a more realistic timeline, or even choose a different LIMS.

In order to avoid this mistake, you need to establish a collaborative relationship with the vendor:

• Provide a detailed project scope to vendor
• Ask the vendor to provide the project timeline
• Align scope with timeline
• Seek assistance from an outside contractor who can help you determine the project scope and timeline

Mistake #4: Select a LIMS solely on the current state of the organization. Companies often make the mistake of choosing a LIMS based on a current “snapshot” of the organization, ignoring future technology enhancements or business needs. This kind of approach effectively negates the whole point of purchasing a new LIMS in the first place by trying to force the new LIMS into the mold of the legacy LIMS or a paper-based process. The result is that you end up purchasing and implementing a LIMS with limited lifespan, or worse – you end up simply repeating your previous LIMS selection and implementation project.

In order to avoid this mistake, you must create a strategic LIMS roadmap (AKA Phase “0”).

• Document current state
• Define future state
• Get input from entire organization – IT, Management, Customers
• Seek assistance from an outside contractor that can help you create a strategic LIMS roadmap

Mistake #5: Select a LIMS based on features rather than requirements. Companies will often base a LIMS decision based solely on the vendor demonstration, allowing “bells and whistles” to drive the decision, while ignoring the “boring” but important items. This leads to gaps between capabilities and requirements being discovered during implementation, and ultimately results in a highly compromised and unsatisfactory implementation.

In order to avoid this mistake, you must perform a proper LIMS requirements phase:

• Establish stakeholder groups
• Allow the establishment of requirements to be an iterative process
• Evaluate all requirements – functional, technical, business, etc.
• Seek assistance from an outside contractor who can help you properly identify your system requirements.

Case Study

As an example of what not to do, consider the case of a clinical diagnostic company that tried to implement a LIMS on their own. The company developed a budget for the project prior to doing a thorough evaluation of project requirements, goals and objectives (Mistake #2). With this budget in mind, the lab manager received a LIMS recommendation from a colleague (Mistake #1), and set up a demo from this vendor. After being impressed with the demonstration (Mistake #5), this vendor’s LIMS was selected and the project moved forward.

Given these mistakes, it was not surprising that the company struggled with the LIMS implementation. The system ended up being implemented in only 1 in 4 labs, and was replaced within 24 months with support from Astrix.

Conclusion

LIMS projects are a serious undertaking, requiring a large investment of money, time and resources. One of the most important aspects of a successful LIMS project is selecting the right LIMS to install. Unfortunately, this is an area where, for a variety of reasons, many companies fail to make the right decision. Given the complexity of modern LIMS projects, it is wise to enlist the support of a quality laboratory informatics consultant like Astrix in order to ensure that you select the right LIMS. With over 20 years’ experience in laboratory informatics, and scientific domain knowledge across hundreds of different platforms, Astrix will support the overall success of your project by helping you:

• assess the current state of your informatics systems and define the future state
• create the business case for your project
• properly define your system requirement’s
• use a methodology that will guarantee you select the propoer LIMS
• develop the proper plan to implement and integrate your LIMS project across the enterprise

The post How to Avoid the Top 5 Most Common Mistakes in LIMS Selection appeared first on Astrix.

Precision medicine is revolutionizing the way we approach modern healthcare by offering medical treatment customized for an individual patient. Medical decisions can now be tailored, or ‘personalized’ to an individual based upon predictions relating to therapeutic responses or risk of disease. Molecular diagnostics enables this novel approach to healthcare through the analysis of an individual’s genetic code and resulting protein expression profile. This rapidly advancing field allows for the determination of a person’s risk for certain diseases through the detection of biomarkers. Molecular diagnostic tests also serve to better inform the selection of targeted therapies and to subsequently monitor the effectiveness of the treatment based upon the resulting changes in the biomarkers.

Until now, informatics solutions required to effectively support the accelerated advancement of precision medicine were not commercially available. With the introduction of the L7|ESP Enterprise Science Platform from L7 Informatics, diagnostic organizations are able to use a single platform for complete end-to-end assay automation and complex data management across the entire workflow. L7|ESP digitizes data, automates processes, and manages the patient precision medicine journey across various silos such as patient consent management, specimen collection, sample preparation, wet lab processing, NGS sequencing, and advanced informatics (including bio-informatics/AI & ML), diagnostic decision support, outcomes tracking, disease registries, and clinical trial management.

In a recent interview with Dr. Erica Tennenhouse, managing editor of Clinical Lab Manager¹, Dr. Vasu Rangadass, President and CEO of L7 Informatics,  shares his vision on how the L7|ESP integrated data management platform can support diagnostic laboratories by breaking down data silos to achieve operational excellence.

Q: What are the greatest informatics challenges that diagnostic labs face today?

A: I think the number one problem that we see is data silos. Typically, the more advanced diagnostic labs have their own home-grown system because they didn’t see any viable solution in the market. As genomics medicine becomes standard of care, especially in the treatment of cancer and rare diseases, we see molecular diagnostics growing rapidly. You want fast turnaround times and accurate audit trails and full data provenance. All of that is not easy to do when you have siloed systems and paper intermixed with Excel spreadsheets.

Q: How is L7’s Enterprise Science  Platform solving these challenges?

A: Traditionally, people use LIMS systems to manage the wet labs and then they use bioinformatics pipelines to manage the informatics analytical pipelines. L7 was created to break down this wall and create one integrated platform. We’ve now expanded our scope beyond breaking down this one wall between wet lab and dry lab to breaking down walls between sample management, sample accessioning, sample inventory management, reagent inventory management, and freezer or location management. We’ve incorporated all of this into one integrated platform called ESP. It’s kind of like an operating system for the lab with different applications, so it’s a much more modern architecture to support the lab of the future where people don’t have to buy multiple different systems. We created one platform and LIMS just happens to be one app and there’s also an inventory management app and a location management app. Customers can pick and choose what apps they want, but all of the data in the lab, both scientific data and operational data, is in one place. We can support digitization, workflow automation, and all of these other functions because we are a single platform to support all the lab needs.

Q: What prevents all labs from adopting an integrated data management system?

A: I think the main bottleneck is that customers already have an existing system. But even customers with existing systems are looking to use ESP as an overlay system on top of their siloed systems to tie all of their siloed systems together. ESP can replace existing legacy systems or overlay on top of those systems and give them a big-picture view of the entire lab. We have customers that are using it in both modes.

Q: What types of diagnostic labs stand to benefit most from your platform?

A: Molecular diagnostics labs—so people doing qPCR for COVID testing or whole genome sequencing for rare diseases or RNA sequencing for cancer or exome sequencing. It’s really all the molecular diagnostics that we are focused on because they are the ones that have the most complexity. But that doesn’t mean that our system is only useful for molecular diagnostic companies; I think we can support any diagnostic. Our system is also fully regulatory compliant, so our customers are using this not only for molecular diagnostics and companion diagnostics but also for manufacturing quality control and manufacturing automation. We have customers both in the precision diagnostics space and also in the cell and gene therapy space using this for doing quality control and manufacturing execution

Conclusion

Precision Medicine is rapidly becoming the new frontier for the future of healthcare. Molecular diagnostic testing is enabling customized approaches to support more effective treatments targeting the personalized needs of individual patients. To help diagnostic testing organizations overcome the challenges brought about by the increasing need to automate workflows, manage large volumes of data, and meet stringent regulatory compliance requirements, the L7|ESP platform provides the innovative tools needed to meet the demanding requirements of today’s diagnostic laboratories.

Why it Matters for You?

Through the elimination of legacy data and process silos, l7|ESP enables the diagnostic laboratory to increase reproducibility and efficiency while decreasing errors and turnaround time to achieve operational excellence.

• Breaks down data silos through integrated data management strategy
• Automates and streamlines all the workflows and data capture across the clinical pathway
• Achieves regulatory compliance requirements: CAP/CLIA/cGMP/CFR part11 and HIPAA
• Integrates with scientific instruments, medical devices, imaging systems, EMR, ERP, lab informatics, and digital pathology systems
• Provides end-to-end tracking of the patient treatment with complete audit and decision support capabilities
• Allows for better collaboration between researchers, physicians, nurses, informaticians by placing them on a single operational platform with full audit capabilities
• Expedites queries about the patient treatment status, by keeping all your data in a cross-referenced single repository
• Provides reliable and easily accessible data documentation to facilitate accurate submissions for regulatory approvals

About Astrix:

Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of science and medicine.

¹E. Tennenhouse, “Breaking Down Data Silos in the Lab”, Oct. 22, 2020, Breaking Down Data Silos in the Lab | Clinical Lab Manager , Clinical Lab Manager, accessed Feb 9, 2021.

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There is a need for a data and process automation platform that allows diagnostics companies to rapidly setup complex assays and automate the entire “diagnostic order” to “report generation” process and collect all the scientific, quality and regulatory data across the process with full data provenance and audit requirements. L7 Informatics’ Enterprise Science Platform (L7|ESP) is a scientific information management (SIM) platform that enables diagnostic organizations to use a single platform for registering and processing samples, running complex analyses, and delivering data to physicians and patients. L7|ESP provides complete end-to-end assay automation and is designed to increase reproducibility and efficiency while decreasing errors and turnaround time.

The Business Challenge

Diagnostics laboratories are faced with many challenges in the effort to digitalize their operations while incorporating advanced technologies such as NGS or AI into their daily workflow:

• Bi-directional integration to various electronic medical records systems in the market
• Lack of real-time visibility to the final report generation so that providers know the expected date of report and plan treatment accordingly
• Complex integrations to new and old instruments across wet lab sequencing and bio-informatics (primary, secondary and tertiary analysis)
• Ability to plan lab resources and manage normal and stat orders on the same system.
• Lack of instrument validation and reagent inventory management that is integrated into the LIMS systems

The L7|ESP Solution

Legacy data and process silos hinder efficiency and science, increasing risk for business and patient.  The L7|ESP platform breaks down data silos through an integrated data management approach that delivers a quantifiable business impact:

• Improved regulatory compliance. L7|ESP is a GLP, GCP and GMP compliant platform
• Increased quality of tests performed due to automated SOPs with a seamless integration between wet lab and computer lab
• Improved efficiency, faster turn-around times and lower cost with more efficient utilization of resources and inventory
• Real-time visibility to “where is the sample?” and the status of the “ where is the report?” to internal account teams as well as ordering providers
• Real time integration to Instruments, CRM systems, Ordering systems and EMR systems
• Verification of inventory and instrument readiness prior to test start
• Automated reordering of reagent inventory
• Integrated freezer and location management

The L7|ESP platform provides diagnostic companies with total visibility over all their operations while digitizing, integrating, and automating the entire precision diagnostic workflow. This streamlined approach will dramatically increase sample throughput and quality assurance in results while providing reliable documentation for regulatory review and compliance (CAP/CLIA/GLP/cGMP).

Why It Matters for You

L7|ESP allows you achieve operational excellence by increasing sample throughput and providing better reproducibility while being a fully integrated and automated process.

• Total digitized visibility across all integrated operations
• Break down data silos through integrated data management
• Elimination of manual processes throughout the entire workflow
• Improved data accessibility to better inform research and business decisions
• Comprehensive validation strategy for improved regulatory compliance
• Increase efficiencies to achieve operational excellence across your organization
• Reduced operational costs and faster time to market

By breaking down data silos with the integrated data management approach of the L7|ESP solutions, next-generation diagnostic companies can provide superior diagnostic service, with reliable and easily accessible data documentation for increased confidence in your results and efficient turnaround time.

About Astrix

To maximize the benefit of implementing transformative technology such as the L7|ESP platform within your organization, working with a proven informatics solutions expert is vital to the success of your project.

Astrix is an industry leader in helping scientific organizations implement and integrate new informatics systems in the laboratory since 1995. Our experienced team of expert informatics consultants bring together technical, strategic, regulatory and content knowledge to provide the most effective solutions to problems faced by scientific organizations.  Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs.  Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey.

The post Turning Silos into Synergies: L7 Informatics Pioneers a Better Way for Precision Diagnostics Process and Data Management appeared first on Astrix.

Technological advances in laboratory instrumentation, along with higher throughput processes, have led to massive increases in the volume of analytical data. One of the main challenges faced by organizations today is turning this vast amount of data into useful information that fuels innovation and enables timely and effective business decisions. In order to manage and process these growing data volumes effectively, laboratories are looking to automate and integrate laboratory operations and processes as much as possible.

Towards this end, integration of laboratory instruments with a LIMS (Laboratory Information Management System) automates laboratory processes and drives operational efficiency by reducing data transcription errors and increasing sample throughput. Instrument integration with LIMS also serves to increase job satisfaction by reducing tedious tasks like manual data entry and writing of results, allowing scientists to spend more time doing the science that leads to innovation. Connecting the information generated by instruments and informatics systems is a key to transforming your laboratory operations, improving product quality, and turning your data into knowledge.

Instruments that are commonly integrated with LIMS in laboratories include:

• GC
• GCMS
• HPLC
• LCMS
• ICP
• Particle Counters
• DNA Sequencers
• Balances
• Titrators
• AA Analyzers

The latest versions of SampleManager LIMS provides a number of effective mechanisms to accomplish instrument integration. In this blog, we will discuss some best practice recommendations when integrating laboratory instruments with SampleManager LIMS in order to ensure that your enterprise maximizes success in ensuring compliance, streamlining processes, improving quality, reducing costs, and driving productivity and innovation in your laboratory environment.

Instrument Integration Tips

Triage which instruments are worth integrating

Before you invest the time and effort to integrate an instrument with SampleManager LIMS, it is important to consider the cost/benefit ratio involved. Implementing an instrument integration can be a time-consuming task – anywhere from a few hours to a several days – so it is advisable to determine if the ROI makes the instrument integration worth pursuing. Some of the factors involved in this analysis are:

• How frequently is the instrument used and what quantity of results will it export?
• How critical are the instrument’s results for laboratory processes?
• Can the instrument’s PC be easily connected to the network so the instrument can be integrated with the LIMS?

For this last point, it is important to consider operating system actualization, network compliance issues such as company IT policies, and the complexity of the data being exported by the instrument.

Go for the Low-Hanging Fruit First

Once you have your list of instruments that make sense to integrate, you’ll want to go for the low-hanging fruit first in order to build project morale and momentum. This means integrating critical path instruments first – those that are relatively straightforward to integrate, high throughput, and add a lot of value to the business.

Laboratories often want instruments such as balances to be integrated due the fact that they are critical to their processes. Balances can be problematic, however, due to a number of factors such as age, connectivity and logistics. An instrument like a GC or HPLC with high throughput and compatible software would probably be a better choice to place at the top of your integration list. Working with a quality informatics consultant that can help you develop an effective roadmap and outline a realistic amount of scope for your project is very important.

Standardize Export Formats

The data exported by instruments either have a fixed format, or can be formatted as the operator desires using exporting templates defined on the instrument software. For this latter case, it is important to configure an export format that is both flexible (allowing all possible instrument methods to work and be imported into the LIMS) and fixed (it does not vary for different methods or different instrument runs). The day-to-day instrument operators should not have the ability to change the export templates. If a different export template is used, parsing scripts developed for the instrument will need to be adjusted to keep it working properly.

SampleManager LIMS Instrument Integration Options

Once the decision is made to integrate an instrument with SampleManager LIMS, the integration method needs to be determined. There are several different ways to integrate instruments with SampleManager LIMS which we will describe below.

Serial/RS-232 interface

The functionality required to integrate serial instruments with SampleManager (e.g. balances, pH meters) is built within the system. These instruments usually require a physical cable connection between the instrumentation and the workstation running SampleManager. The COM port parameters can be defined within SampleManager for the instruments.

Different setups/hardware options (Serial Device Servers) can be explored if multiple instruments need to be connected through this serial interface to the same SampleManager workstations; or to make the same instrument available to different SampleManager workstations through the network. Some VGL customization is required for this setup.

Instrument Manager

Also known as SM-IM, or the “SampleManager Instrument Manager” module. The SM-IM module allows SampleManager to read result files from instruments. Virtually any instrument that is networked and can produce a result export in a file format can be integrated with SampleManager using this module.

The SM-IM module utilizes parsing scripts (to parse the important information from a result file), mapping scripts (to map the parsed data to SampleManager entities) and an alias table (to map specific entries between the instrument and SampleManager, like name of analysis methods and results). Each instrument to be integrated will have a parsing script, mapping script and an alias table defined on the SM-IM module. The instrument is then configured to export files to a specific network folder, where SM-IM interface will process the files and send the results to SampleManager (through LIMSML).

This SM-IM module is easy to use and configure. The main limitation is that it is a unidirectional interface, so it won’t allow SampleManager to send data to the instrument (such as list of samples to be analyzed).

New SM12.1 LES Instrument Integration (“New” SM-IM)

Together with the SampleManager LES functionality (standard on SM12.1), Instrument and Workflow functionality were extended to support manual Instrument Integration that is compatible with the SM12+ web client. The Instrument Entity has a tab for configuring Integration properties, which includes the ability to specify a Data Source for the integration.  Data sources can be:

• Emulated
• Serial Port
• Directory
• Web Request
• File Prompt

Parsing scripts and Alias table can be defined within SampleManager for the LES Instrument Integration.

Once the test is assigned to an instrument on the SampleManager result entry screen, the system will allow results to be imported based on the Serial/Data Source configuration defined for the instrument. This is a unidirectional (Instrument  SampleManager)  instrument interface mechanism.

The SampleManager Workflow Entity was also extended and has new nodes to streamline instrument integration.

Integration Manager

Integration Manager is a stand-alone Thermo Fisher application/product that allows for bi-directional integration with instruments, services or third-party applications using the concept of integration points. When utilized for instrument integration, Integration Manager can be configured to send SampleManager information to the instrument (usually the list of samples and some sample properties), and to retrieve results back from the instrument (usually exported to files on a network folder). More complex setups with multiple interfaces and multiple integration points can also be used to address very complex integration scenarios.

Integration Manager is a stand-alone product with its own license, user interface and database objects that is designed to work with many different systems, not just SampleManager. Integration Manager acts like a translator of different languages from disparate data sources, accepting and delivering data in the format appropriate to each intended recipient.

When used specifically for SampleManager instrument integration, Integration Manager allows the creation of transformations (similar to parsing and mapping scripts) and alias tables and makes available ‘File Agents’ and ‘SampleManager’ agents to complete the integration.

Chromeleon Link

Specific functionality to integrate SampleManager with Chromeleon (a CDS from Thermo Fisher Scientific) was released with SM 11 and is being continuously enhanced on service releases and newer versions of SampleManager (12 and 12.1).

This interface allows bidirectional communication between SampleManager and Chromeleon, where:

• SampleManager can send Sequence List to the Chromeleon instrument.
• SampleManager can import the Sequence information and results seamlessly from the Chromeleon instrument.
• Chromeleon software can search for Sequence information directly on the SampleManager system (through Batches and Standards Configuration on SampleManager) using Chromeleon e-Workflow wizard.

Custom Instrument Integration

Customers sometimes choose to customize their instrument interfaces (bi-directional from SampleManager –>Instrument and from Instrument –> SampleManager) and do not use any of the tools available from Thermo Fisher. While this allows flexibility, like any other customized solution, it is not sustainable for a long-term strategy and will require a lot of attention as SampleManager evolves and upgrades take place. Usually maintenance costs of custom solutions are very high, so all other options should be exhausted before going down this path.

Conclusion

Whether you have old instruments that were not integrated with SampleManager during your initial implementation, or new instruments that have come online since, a SampleManager upgrade (or a new implementation) is a convenient time to integrate instruments with the system. Effective instrument integration is crucial to improving your organization’s IP protection and SampleManager adoption and utilization rates, and a key factor in enhancing productivity, efficiency, data integrity and innovation in your laboratory environment. Automating your laboratory environment through effective instrument integration, however, is best accomplished through a close partnership with a quality informatics consultant. As a long-standing Thermo Fisher Scientific’s services partner, Astrix is uniquely positioned to help you optimize your SampleManager LIMS implementation and instrument integrations.

The post Tips for SampleManager LIMS Instrument Integration appeared first on Astrix.

A contract research organization (CRO) providing full-service clinical development services to biopharmaceutical and medical device sponsors was interested in implementing one centralized system to manage their biorepository. They choose to install the LabVantage pre-packaged LIMS designed for biobanking (LabVantage Biobanking), as this system is pre-configured to address all aspects of biorepository management.

The customer worked with LabVantage Professional Services to implement LabVantage Biobanking into their laboratories with no customization of the system. Once LabVantage Biobanking was installed, it needed to be validated. As a premier LabVantage consulting partner, Astrix Technology Group specializes in validation services for LabVantage LIMS. The customer therefore decided to partner with Astrix to fulfill its LabVantage Biobanking validation requirements.

Services Provided

Astrix provided two primary resources to the customer to accomplish the necessary validation activities for LabVantage Biobanking:

• Validation Manager – This resource had overall responsibility for all validation services performed and worked to keep validation activities within budget and in alignment with the overall LabVantage Biobanking implementation project plan. The Validation Manager interfaced with both the LabVantage Project Manager and customer resources.
• Validation Analyst – This resource was responsible for the planning, construction and execution of all validation-related Services.

The work the Astrix Team did on this project included:

Validation Plan. The Astrix team created a Validation Plan document that defined the objectives of the validation, the approach for maintaining validation status over the full software development lifecycle (SDLC), and satisfied all regulatory policies and industry best practices (e.g., GAMP 5). The Validation Plan detailed the following:

• Project Scope – outlined the parts of the system that needed validation (those parts of the system that would be utilized by the customer), along with deliverables/documentation for the project.
• Testing Approach – Defined the types of data that would be used for testing, along with the kind of scenarios that would be tested.
• Testing Team and Responsibilities – Listed the members of the validation team, along with their roles and responsibilities in the validation process.
• Acceptance Criteria – Defined the requirements that need to be satisfied before the system is considered suitable for use in regulated activities.

Requirement Gathering. The Astrix Team gathered the necessary information regarding the customer’s intended use of the system that would be used to guide a risk-based approach to validation testing. The following documents were finalized in this phase:

• User Requirements Specification (URS). The Astrix Team worked with the customer to author the URS, which clearly defined what the system should do, along with any operational (regulatory) constraints.
• Functional Requirements Specification (FRS). The Astrix Team worked with the customer to review/revise the FRS, which defined how the system will look and function for the user to be able to achieve the user requirements.
• Design Specification (DS). The Astrix Team reviewed the LabVantage Biobanking DS that were created by the implementation team.

Risk Management. The Astrix Team conducted an analysis of failure scenarios to determine scope of validation efforts. A risk management plan (RMP) was created to document the findings and recommendations which came out of the analysis.

System Qualification and Interim Reports. All installation qualification protocol (IQ) activities associated with infrastructure of the hardware, software, and instrument interfaces were completed by the customer with the assistance of other third-party vendors. The Astrix Team reviewed IQ documentation, and conducted the following qualification activities:

• Operational Qualification Protocol (OQ) with Test Scripts – Wrote test scripts at subject matter expert (SME) level and conducted the testing.
• Performance Qualification Protocol (PQ) with Test Scripts – Wrote test scripts at SME level and conducted the testing.
• Traceability Matrix – Documented the OQ and PQ results in a Traceability Matrix

Closure & Deviation Management. The Astrix Team worked to document the results of the project by authoring the following documents:

• Validation Summary Report (VSR) – A review of all activities and documents against the Validation Plan.
• System Release Document – Documentation that validation activities are complete and that the system is available for intended use.

Results Delivered

The contract research organization (CRO) engaged with the professional services group at LabVantage to install and configure the pre-packed LIMS for biobanking  Astrix Technology group then created a Validation Plan document that defined the objectives of the validation, the approach for maintaining validation status over the full software development lifecycle (SDLC), and satisfied all regulatory policies and industry best practices.  The validation plan detailed the project scope, testing approach, testing team responsibilities, and acceptance criteria. Additionally, Astrix provided the Validation Manager and the Validation Analyst resources to perform the necessary validation activities.

The Astrix Team then gathered the detailed information regarding the customer’s intended use of the system that was used to guide a risk-based approach to the validation testing. The documentation provided during this phase of the project included the User Requirements Specification (URS), Functional Requirements Specification (FRS) and Design Specification (DS).

During the final phase of the project, the Astrix Team conducted an analysis of failure scenarios to determine scope of validation efforts. A risk management plan (RMP) was created to document the findings and recommendations which came out of the analysis. The system qualification was managed in two stages.  The IQ was completed by the customer with the assistance of other third-party vendors. The Astrix Team reviewed the IQ documentation, and conducted the OQ and PQ, with all and results documented in a traceability matrix.  At the completion of the validation, the Astrix Team provided a Validation Summary Report (VSR) and the System Release Document indicating that all validation activities were completed, and that the system was available for intended use.

The LabVantage validation performed in this project by the Astrix Team met the customer’s needs which resulted in significant improvements to operational efficiency, regulatory compliance and data integrity for their centralized LabVantage LIMS and biobanking system. The customer was extremely satisfied with the results of this project having accomplished all of the intended business goals.

The post Case Study: LabVantage LIMS Biobanking Validation for a Contract Research Organization appeared first on Astrix.

Reasons for M&As are numerous and diverse and include:

• Improve profitability
• Increase efficiency
• Automate manual processes
• Shorten time to value
• Enhance business intelligence
• Acquire R&D data
• Expand product portfolio
• Maximize growth
• Innovate core business models
• Mitigate technology disruption
• Implement game-changing strategic moves

While the potential benefits of an M&A are compelling, there are also potential pitfalls lurking that can swallow large amounts of both money and resources. One of these potential pitfalls involves the problems that can occur when attempting to merge two different company’s data infrastructures.

Integrating and consolidating the master data in disparate enterprise systems is one of the most critical, yet costly and time-consuming, challenges that need to be met in an M&A. In part 5 of our LIMS master data best practices series, we will discuss best practices that can help guide the strategy for consolidating and managing LIMS master data in mergers and acquisitions.

Master Data Best Practices for M&As

Any organization undergoing an M&A will be significantly increasing IT infrastructure and the amount of master data that needs to be managed and maintained, as well as the cost of doing so. As such, each application should be analyzed to determine how it aligns with the company’s future-state vision and brings value to the organization over its lifetime in a process known as application portfolio rationalization.

There is also a strong need to aggregate and consolidate data to provide for post-merger operational efficiency and also quick wins for the short term. Merging and harmonizing disparate LIMS and their data into a single functional operating environment is not a simple task and can put enormous strain on a company’s IT department if not planned and executed effectively. Even if you don’t need to merge two separate LIMS into one, master data in your LIMS will need to be adjusted to accommodate new and/or altered workflows. Having a scalable master data plan in place, as we discussed in part 3 of our LIMS Master Data Best Practices series, can help to facilitate this process.

Effective master data management (MDM) during an M&A is an important enabler of everything from business continuity to post-merger innovation. Some of the key aspects of a successful master data management (MDM) strategy for LIMS master data include:

Conduct an Audit of Systems and Data. When a company integrates an acquisition or engages in a merger, the sooner the data integration team is involved, the smoother the integration is likely to be. The first thing that should be done by IT during an M&A is to conduct a full system and data inventory in order to understand and document the current data landscape. Some data challenges to consider and document include:

• Data may be captured, managed and maintained differently
• Data standards may be different
• Data processes, procedures and methods may be different
• Data quality may be different
• Data strategies may be different

An inventory of this nature can be difficult to accomplish if either organization lacks good IT and data governance/documentation This is why it is important to have change control procedures in place A good place to start is to identify business, subject matter and data experts across both organizations and form a data team to research and determine what documentation is available for this initial phase. A few key questions to ask when trying to document the current data landscape include:

• Where is the master data currently located (systems, apps and files)?
• How does data traverse these different systems?
• Who owns data?
• Who manages data?

If a change control procedure (see part 4 of our LIMS Master Data Best Practices series) is in place that includes a data migration plan, the master data plan, and how to conduct reviews and audits, these questions will be easy to answer.

Do Strategic Planning. Once the current data landscape is documented, the next step is mapping out the future state workflows that will determine your master data configuration. Laboratory workflows utilize LIMS master data, and an M&A means workflows will likely need to be altered and new workflows added into the system. The first step in the process is for business analysts to conduct a series of interviews with business stakeholders to document the current state of laboratory business processes, technology and IT architecture in both organizations. In addition, analysts should discuss the merger at a high level with the organization’s management team to understand the goals, aspirations and objectives of the desired future state of the laboratory.

Once the current state is fully documented, the project team will work to create a future state model by defining the goals, workflows and requirements of the desired future-state. If you choose to harmonize and standardize laboratory operations on a new LIMS or a legacy system, the technical, business and user requirements from the strategic planning phase are utilized to guide the technology selection, implementation and integration process.

Map Out the Data Structure. With future state workflows established, the next steps are determining the data fields to be entered into the LIMS, establish naming conventions, and mapping out the data structure. We covered this in detail in part 2 of our LIMS Master Data Best Practices series. In addition, if the Master Data Plan we discussed in part 1 of our series exists for the LIMS that will be used in the new operating environment, the process of mapping out the new data structure will be much easier. Of course, this Master Data Plan will need to be updated to reflect the new operating environment. Once the data structure is mapped, configuration of the LIMS can begin.

Standardize and Migrate Master Data. Master data from the acquired company may need to be standardized before being migrated into the LIMS that will be used for the new unified operating environment. Data migration for a project of this nature can be a significant challenge The Data Migration Plan we discussed in part 4 of our series should guide this process. Master data from the acquired company will likely need to be extracted, translated and loaded into a new location. Questions to ask that help to determine your data migration/management strategy include: How are we going to get master data out of the acquired company’s systems and into the LIMS? How are we going to harmonize data across multiple sites?

Data management/migration for an M&A is typically a big job. It is therefore important to formulate a Master Data Management/Migration Strategy before any migration or LIMS configuration has happened in order to avoid significant time and cost overruns as the project proceeds, as well as minimal disruption to your lab operations during migration activities.

Once the data has been migrated, regulatory requirements mandate that it must be validated to make sure it is accurate and has been transferred properly. This validation should be guided by your Change Control procedures. Even if your company is not in a regulated industry, validating migrated data is important to make sure your data is sound.

Conclusion

Mergers and acquisitions can help drive your competitive advantage, but they can also paralyze a business and generate significant unexpected costs that can serve to minimize the value proposition of the merger. Following the best practice recommendations described in the blog help to establish a single version of the truth in your LIMS, something which is critical to ensuring your laboratory maintains operational efficiency, data integrity, and regulatory compliance. Effective LIMS master data management in an M&A is also important to ensure your laboratory continues to produce the valuable business intelligence that drives innovation and competitive advantage for your organization.

Astrix is a laboratory informatics consulting firm that has been serving the scientific community since 1995. Our experienced professionals help implement innovative solutions that allow organizations to turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance. If you have any questions about our service offerings, or if you would like have an initial, no obligations consultation with an Astrix informatics expert to discuss your master data strategy or LIMS implementation project, don’t hesitate to contact us.

About Astrix Technology Group

Scientific resources and technology solutions delivered on demand

Astrix Technology Group is an informatics consulting, professional services and staffing company dedicated to servicing the scientific community for over 20 years.  We shape our clients’ future, combining deep scientific insight with the understanding of how technology and people will impact the scientific industries. Our focus on issues related to value engineered solutions, on demand resource and domain requirements, flexible and scalable operating and business models helps our clients find future value and growth in scientific domains. Whether focused on strategies for Laboratories, IT or Staffing, Astrix has the people, skills and experience to effectively shape client value. We offer highly objective points of view on Enterprise Informatics, Laboratory Operations, Healthcare IT and Scientific Staffing with an emphasis on business and technology, leveraging our deep industry experience.

For More Information

For more information, contact Michael Zachowski, Vice President at Astrix Technology Group, at mzachowski@astrixinc.com.

The post LIMS Master Data Best Practices Part 5 – Mergers & Acquisitions appeared first on Astrix.