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.

The ability to combine NGS-generated genomic data with clinical data, for example, has revolutionized the Life Science industry, spawning the development of personalized cancer treatments and the field of Precision Medicine. Commonly used NGS processes (e.g., whole exome sequencing, chromatin immunoprecipitation sequencing, DNA target-based sequencing, RNA sequencing, etc.) are leading to many important discoveries and innovative processes in both research and patient-centered settings.

With the ability to generate multiple terabytes of data in a single run, however, widespread use of NGS technology has led to massive datasets for researchers. Managing this data has now become a central challenge for genomics laboratories and biotechnology companies. While data storage options have become relatively inexpensive in today’s digital age, processing and analyzing these enormous datasets has become the new bottleneck.

Scientists conducting research using genomics data need to be able to effectively compare genomes across patient cohorts and retrieve the associated sample information. In this context, laboratory information management systems (LIMS) that archive and organize data in a centralized database have become a necessity for genomics labs and biotechnology companies. LIMS allow scientists to intelligently examine these massive datasets to drive research decisions.

Laboratories looking to implement a LIMS face a dizzying array of options, however. There are now several dozen LIMS vendors on the market, including LIMS that are specifically designed for genomics laboratories. In this blog, we will discuss some of the key features a LIMS serving a genomics laboratory should have and provide an overview of a LIMS selection methodology that helps to ensure you make the right choice for your unique laboratory environment.

Important Criteria for Selecting Genomics LIMS

Genomics research often involves complex, multi-step workflows that frequently need to be adjusted and can span several different laboratories. The experimental complexity of genomics research, along with the massive data volume, create unique challenges for researchers and/or laboratories looking to manage and analyze genomics data. In addition, regulatory bodies have been working to catch up with this dynamic field, and complex guidance and regulations are beginning to emerge that seek to maintain testing accuracy and reliability.

When properly implemented, a LIMS solution can dramatically improve laboratory efficiency and effectiveness, along with regulatory compliance. While system requirements that are unique to your lab should be the foundation of every LIMS selection process, there are number of selection criteria that are typically important for a genomics LIMS. Some examples include:

Easily configurable and customizable. With the cutting-edge research being performed in genomics labs, workflows, protocols, methods and technologies are constantly changing. Genomic LIMS need to be adaptable to help labs accommodate changing technologies and methodologies. Instead of having to call up the LIMS vendor every time something needs to change in the system, the lab team should be able to quickly configure the software. The LIMS should also come with a flexible application program interfaces (API) that allows a lab team with programming expertise to easily customize the system. The bottom line is that the rapid timescales associated with NGS require an easily configurable and customizable LIMS that will enable labs to avoid programming delays and make changes quickly.

Easily integrates with next generation sequencing instrumentation. Integrating instruments with LIMS is one of the primary ways that LIMS improve workflow efficiency in labs. Towards this end, any LIMS utilized by a lab with NGS equipment should integrate (generate and consume instrument files) readily with major next-generation sequencing instrumentation. In order to help automate workflows and speed analysis, the LIMS should:

• Automates the process of setting up a run – scientists specify the samples they want to use, and the LIMS automatically generates the files the sequencer needs for the run.
• Tracks the quality of sequencing data coming from the instruments – it is highly inefficient for labs to wait until the run are complete before evaluating data quality.
• Tracks results – scientists should be able to easily locate the information associated with any particular run.

A good LIMS will enable scientists to avoid having to organize and track sequencing data so they can spend more time on analysis and innovation.

User specific interfaces. NGS work involves collaboration between many different types of scientists to extract the insights that drive innovative medicines. Given each of these scientists needs access to different types of information and performs different tasks, the LIMS needs to be able to provide user specific interfaces to maximize productivity. User specific interfaces are also necessary for data security – users should only have access to the information they need to do their jobs effectively.

Comprehensive sample tracking. NGS biologics add significant complexity to sample tracking and workflows, including the need to track sample lineage and progeny over time. Given this complexity, genomics labs often struggle to effectively track the samples (and associated metadata) used to conduct a particular experiment. To be able to effectively analyze the enormous quantities of data the NGS produces, scientists need to be able to track all the granular details unique to genomics samples throughout the workflow (from sample submission to result reporting). This will allow researchers to see and interrogate sample history over its full lifecycle in a single centralized system, ultimately making it easier for scientists to set up and validate experiment runs.

Compliance Support. Given that genomic research typically involves human samples, genomics laboratories must adhere to a variety of regulations – CLIA, GDPR, HIPAA – administered by US and international agencies in addition to GxP and 21 CRF part 11. There are also frequently stringent state regulations for genetic testing, in addition to both laboratory and scientific professional organization (e.g., College of American Pathologists, Association of Molecular Pathology, American College of Medical Genetics and Genomics) guidelines that need to be integrated into laboratory operations.

As such, the LIMS solution chosen will need to have a robust set of controls that support compliance with applicable regulations and standards on data integrity, validation and privacy. Additionally, the project team needs to have the skills, knowledge and experience necessary to properly develop and apply these controls during the implementation so as to enhance and ensure regulatory compliance for your business.

LIMS Selection Methodology

While the above-mentioned selection criteria are usually applicable for a LIMS serving a genomics lab, every lab is unique, and care should be taken to apply a comprehensive methodology that ensures the best LIMS for your lab is chosen. One of the biggest mistakes companies make when selecting a LIMS is to omit the business analysis necessary to ensure you select the right LIMS for your unique laboratory. Organizations purchasing a LIMS typically have many workflows in place that incorporate manual processes and information stored in disconnected silos such as spreadsheets, emails and paper notebooks. These workflows will need to be completely revamped and optimized to take full advantage of the productivity and efficiency gains that a LIMS can offer.

The first step in any technology selection process should be thorough workflow and business analysis that serves to maximize business value for your organization. Such an analysis utilizes business analysts with domain, industry and system knowledge to document the current state of laboratory operations, as well as an optimized set of future state requirements that will encompass the flexibility necessary for genomic workflows.

Once a set of optimized future-state requirements are generated, it may also be necessary (for large organizations) to design a laboratory informatics architecture that is aligned with business goals, along with a roadmap to deployment, before engaging in a proper technology selection process for your organization. With the proper foundation laid for your selection process in this way, you ensure that the LIMS selected for your laboratory will maximize business value for your organization.

Conclusion

LIMS have proven to be an invaluable tool for laboratories across a wide range of industries for over 30 years now. Due to the unique demands of next generation sequencing, selecting the right LIMS for a genomics laboratory can be a challenging endeavor, however. Genomics labs typically need a flexible, scalable, regulatory-compliant, multifunctional LIMS with a low total cost of ownership (TCO) that satisfies most or all of the selection criteria described above.

While several vendors now produce LIMS specifically designed for genomics labs, some of these systems can be rigid and prescriptive about workflows. A comprehensive methodology that includes a thorough evaluation of hosting options should be followed to ensure that you select the best LIMS for your laboratory.

Astrix  has over 20 years of experience facilitating successful LIMS selections and implementations in pharmaceutical and biotech companies. Our experienced professionals have the experience and knowledge to help you select a LIMS that will allow your organization to turn data into knowledge, increase organizational efficiency, improve quality and facilitate regulatory compliance.

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