• 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.

Creating a new generation of laboratory workflows requires a paradigm shift in the status quo of your daily operations. Digital transformation initiatives, prevalent in most scientific industries today, seek to automate and digitalize laboratory processes, but the reality is that many of these efforts fall short of the mark.

In spite of the advances made in scientific software, research is still bound to its paper-based origins. Even in the most “connected” lab, scientists still capture data and observations manually as they perform their experiments. LabVoice revolutionizes the concept of the lab of the future with the hands-free laboratory digital assistant, used by scientists to optimize laboratory processes and transform interactions with their instruments and software.

Smart Technology for the Smart Lab

Working with samples in a laboratory is a ‘hands-on’ endeavor. Documenting sample information, aliquoting or testing various compounds, and recording observations and data are just a few of the routine tasks required to conduct science or make sure the lab runs smoothly. Laboratory digital assistants help manage these operations by completely freeing your hands to do the work you need while capturing or accessing this important information and controlling lab instrumentation.

The LabVoice digital assistant enables data entry for all types of lab activities such as a hood, glove box, and biological containment or sample preparation areas. From simple notes to structured procedures, LabVoice will help you record, access, and track your data, including scanning barcodes, taking pictures and recording videos.

The digital assistant allows you to connect to your lab software and equipment, for data capture and instrument control to improve efficiency, compliance and safety in the following ways:

• Paper-free sample management: Scientists can use the LabVoice mobile app’s built-in camera to take photos and videos, scan barcodes, capture text using OCR, and create reminders or replenish inventory on the fly.
• Hands-free Data Collection & Documentation: Scientists can use their voices to capture observations and record measurements. This is particularly useful when working with gloved hands such as required in animal facilities or biological safety facilities.
• Faster, more efficient operations: Guided process execution streamlines various routine tasks such as the manual picking, registration and requisition of samples.
• Connect to lab software: Connect to your scientific software including LIMS, ELN, SDMS, and CDS, enabling scientists to document or access nearly any attribute associated with the sample or analysis.
• Training through guided process execution: Mentor new personnel, walk a user through a protocol, SOP, or any process step-by-step. As they progress, the digital assistant can gently remind technicians of important safety information, ancillary instructions, helpful tips, and warning about any deviations from expected values, helping eliminate errors in data.

Working with samples and instruments is a routine part of laboratory activities. With LabVoice you can access any instrument, application or data simply by speaking your commands. LabVoice listens, facilitates your request, and records the details so you can keep your hands free to focus on what’s most important—the science!

Summary

LabVoice smart technology brings you a voice assistant to simplify your laboratory processes by creating a common human-lab interaction that allow scientists to focus on the science. By seamlessly integrating with your existing lab infrastructure (instrument, software, databases), a new generation of lab workflows enable hands-free data capture, enhanced SOP & method compliance, and robust safety protocols to improve operational efficiency and position your lab for the next scientific breakthrough.

Why it Matters for You

Technology is advancing at an accelerated pace, requiring organizations to digitally re-invent today’s approach to science. In spite of the many initiatives underway in which organizations seek to digitally transformation their operations, the reality is still a heavy reliance on manual, paper-based processes that are barriers to progress and productivity.

In this blog you will learn about the impact that LabVoice digital assistants bring to efficiency, data quality, and compliance and how to:

• Improve data quality through an integrated digital-assistant, instruments, and ELN
• Free up a scientist from a two-person sample accessioning process
• Use digital assistants for hands-free in vivo research

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face. Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post The Voice-enabled Digital Lab of the Future appeared first on Astrix.

By Dave Dorsett, Principal Software Architect at Astrix

Technology has changed nearly every aspect of our daily lives and has rapidly redefined the way we do science. The digital disruption brought about by the vast influx of innovative technologies has created both an increasing dependency on technology and accelerated digitally-enabled science. The emergence of the Internet of Things (IoT), artificial intelligence (AI), and machine learning (ML) provides the basis for intelligent automation and big data-driven insights.

These and other digital technologies are capable of boosting productivity and transforming operations into the lab of the future. Lab connectivity holds the key to unlocking insights powered by this digital revolution leading to the next scientific breakthrough. Still, many science-based organizations are struggling to leverage these tools.

Digital transformation of R&D embodies the principles of digitization to remove any paper-based processes, but within a framework of re-examining the entire work process. Rather than just moving the current state of data generation and capture to electronic form, digital transformation focuses on broader questions, such as what data is used by whom for what purposes, and if there is a more direct route to accomplish the scientific goal. This makes it explicitly cross-functional and opens opportunities for improvement in overall operational efficiency and productivity in the larger business processes.

How does an integrated lab work?

The concept of the integrated lab is a completely digital lab environment, where manual work is eliminated, materials and samples are transparently managed, and work processes are connected across all instruments and flow seamlessly across any operational systems needed to support the work. These digital workflows lead to overall improved data quality through automation and explicit connectivity—the operational systems share critical common metadata and expose their data for use by other systems openly and as needed. A characteristic of this type of data is referred to as a FAIR¹. The four foundational principles of FAIR data are: findability, accessibility, interoperability, reusability. Data flowing into and out of the lab environment must adhere to FAIR principles to achieve the benefit of “data-readiness” from the digitally integrated lab of the future.

Disconnected systems have, thereby, become a major pain point in the lab. Managing mixed digital and non-digital processes using scientists to transport data is decreasing operational efficiency and raising questions of quality and completeness with respect to data. To overcome the challenges arising from the continued use of non-digital processes, today’s modern lab needs to re-examine fundamental data flow.

Examining the generation of data as an example, use of IoT (smart) technology to improve data collection integrity and automatically associate the intrinsic metadata of who, what, and where the data was created with the instrument results. In this future state, all lab instruments and equipment are connected to cloud storage, where it can be processed and combined with other relevant enterprise data for analysis. This improves the relationship between the instrument data and its use, and all consumers of the results are given direct access to the primary instrument data used to support the results.

As R&D organizations continue to operate with a global footprint, use outsourced CROs/CMOs services, and collaborate with external partners, the need for an integrated digital lab becomes imperative for managing the secure and compliant bi-directional flow of data across a multitude of business and informatics platforms.

Achieving lab connectivity

Digital connectivity forms the basis for transformation in lab productivity. It is common for many scientific labs to have multiple deployments of LIMS, ELNs, and analytical instrumentation that is duplicative, siloed, aging, and requires manual operation or transcription. To achieve a truly transformative lab environment, all people, processes, systems, and data must be connected and harmonized into a rational, scalable system and data architecture.

The most effective approach to a digital transformation starts with a thorough current state scientific process analysis. This involves analysis and documentation of the lab workflows in practice, including the current use of systems across current lab equipment and functions. This current state assessment provides a map of “pain points”—inefficiencies, wait states, unnecessary duplication of work and data, and manual creation or re-creation of data. This assessment then guides the development of the optimized future state work processes that includes selected process improvements arranged in a roadmap. The roadmap is important: resolving all the pain points in a single step is not pragmatic, furthermore, not all the pain points will be independent or have the same importance. In practice, resolving even some of the major issues should be reason to re-evaluate the workflow to ensure the next steps are the better ones.

The diagram below is a visual representation of the complexity of an overall digital transformation as applied to various priorities of a specific organization. Although there are different digital transformation journeys, the overall goal remains to connect workflows to move from a traditional R&D state to a true digitized R&D environment.

Without a clear strategic plan, organizations often rush to implement solutions in ways that do not support the future goals of the business. There are tools and services available in the marketplace today that provide the expertise and resources needed to analyze, plan, and execute a successful digital transformation program for your organization that will ultimately lead to increased productivity for the lab. Digital transformation is not a classic IT project. The effort involved is different from implementing a vendor system. Digital transformation is a program to re-think the way in which science is done.

Follow the data

Data is the most valuable asset of modern science. Gaining access to the insights that data hold is the key to data-driven R&D. An integrated laboratory provides the digital connectivity required to make R&D data more effective by making it available when and where it is needed. Digitization can eliminate workflows currently running on paper, Excel, PowerPoint, and email. Digital transformation, however, identifies and stratifies data based on its use and develops additional connectivity among data and the scientists who use it, allowing scientific processes to become “data-centric.” This transformation also enables advanced analytics, applying algorithms and AI/ML to automate and optimize R&D results through descriptive and predictive modeling.

Journey to the cloud

In the past decade, organizations have been adopting a “cloud-first” or “cloud-only” approach. When applied fittingly, cloud-based IT solutions offers flexible, lean, cost-efficient infrastructure that opens the door for more digitization, and hence digital transformation. The key is flexibility. Use of cloud alone may be necessary to achieve the flexibility needed to support digital transformation, but it is not sufficient.

Cloud infrastructure should permit companies to focus more on the use of technology rather than the care and feeding of the technology itself. Unfortunately, this is not always the case. In fact, cloud infrastructure in the real world can be more inflexible than using on-premise infrastructure. This irony is typically the result of the lack of transformation in the IT organization and can be a significant barrier to digital transformation.

Collaborations among global sites and external business partners require moving enormous amounts of data quickly and securely across the enterprise. The need for an agile, cost-effective IT infrastructure and the right technology in place to support these efforts is a vital requirement for achieving the integrated lab of the future.

Additional digital lab applications

Digital transformation provides benefits to the overall operational efficiency of the lab while improving data integrity throughout the process, but how can you take full advantage of these gains in productivity from a lab management perspective? One of the most impactful benefits of the digitally integrated lab is the ability to visualize laboratory operations.

Digital connectivity facilitates collaboration between teams, sites, and external partners for sharing of scientific information and data. As enhanced-reality technologies become more available and suited to the laboratory environment, the ability to take your lab operations to another level through hands-free or voice-activated operation can enhance complete data collection.

One of the more labor-intensive tasks within any lab environment is the tracking and ordering of consumables. An integrated lab environment can enable you to simplify this process via automated RFID tracking of consumables usage coupled with e-commerce platforms for the replenishment of these supplies. These are examples of opportunities to improve lab productivity through digitalization leading to streamlined scientific processes and cost savings that contribute to the bottom line.

Productivity speeds innovation

Digital transformation allows R&D organizations to increase scientific efficiency through workflows that support and optimize the work of scientists. These improvements ultimately lead to an overall reduction in operating costs and higher ROIs, but the significant gains in productivity lead to the most dramatic change brought about through digital transformation—innovation.

Simply put, increased productivity allows scientists to see more in less time with less effort. Speed is the biggest promise of digital transformation, enabling scientists to free up valuable time and resources to focus on what is important—the science.

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face. Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

References

¹Wilkinson, M., Dumontier, M., Aalbersberg, I. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data3, 160018 (2016). https://doi.org/10.1038/sdata.2016.18. Accessed December 28, 2021.

The post The Integrated Lab – Lab connectivity powers data-driven discovery appeared first on Astrix.

Cell and gene therapy hold enormous potential for revolutionizing healthcare. New treatment methods for cancer, heart disease, and disorders of the blood and immune system using these innovative approaches are poised for mainstream alternatives to traditional medicine.

Research in the field of cell and gene therapy is rapidly advancing, leading to therapies that slow the progression of diseases and even cure them. New disease targets continue to emerge in the absence of effective treatments for incurable conditions such as HIV, Lupus and Multiple Sclerosis. While the science behind cell and gene therapy has evolved exponentially, the development of a scalable, digitally-reproducible cell culture manufacturing process presents a substantial bottleneck in realizing the full benefit of these life-saving therapies. CellPort Software solves the difficulty of scalability in tech transfer through bioprocess digitalization.

Complex Challenges in Bioprocess Scale-up

The tremendous progress being made in the development of potential cell-based therapies is hindered by the complexities involved in the cell manufacturing process. Large-scale expansion from laboratory scale protocols can be a daunting task due to the high variability of biologically-based starting materials, scientists’ techniques, and a multitude of parameters affecting cell proliferation and viability throughout the process.

Factors such as cell type, bioreactor design, and growth conditions also have a dramatic effect on the overall yield in industrial bioprocess — an estimated 50% of all preclinical research in the U.S. is not reproducible, and 36% of that irreproducibility stems from biological reagents and reference materials, including cells, creating significant financial risk to biopharma companies.

When one considers all of the elements involved in bringing a cell culture process from the initial growth of the cells in a small-scale lab, to an industrial scale manufacturing facility, all the way through to the final therapy, minimizing variability within the process becomes crucial to maximizing product quantity and quality without losing the ability to reproduce results.

Bioprocess Optimization Through Digitalization

Planning a successful commercial scale process for biopharmaceutical production starts in the laboratory. Digitalizing the upstream workflow provides the platform for automation, standardization, and optimization of critical components within the R&D process, beginning with early stage research, enabling digital reproducibility that can be carried all the way through downstream manufacturing.

CellPort Software revolutionizes cell-based manufacturing by digitalizing Standard Operating Procedures (SOPs) to ensure consistency, compliance, auditability, and visibility for improved operational efficiency and effectiveness that cannot be achieve with manual protocols and legacy systems.

The CellPort Cell Culture Suite focuses on managing all cell-based assay workflows, activities, equipment, materials, personnel, data/calculations, locations and projects used in most experimental and biomanufacturing situations through a compliant, cloud-based SaaS application. Standardizing operating procedures across the R&D process creates the predictability necessary for cell and gene therapy development and manufacturing by managing the major sources of variation in assay execution:

• Scientist/Operator Technique
• Staff Knowledge and Training
• Equipment Calibration
• Ambiguous Assays
• Origina and Lilfetime of Materials
• Cells and Cell-based Calculations

Navigating the Regulatory Compliance Landscape for Biologicals

Guidelines for the manufacture of cell-based therapies are changing as quickly as the science itself. Manual, disconnected systems and workflows introduce inefficiencies into the manufacturing processes and are not sustainable practices for achieving compliance against the rapidly evolving regulatory landscape for the production of biologicals.

The 21 CFR Part 11-compliant CellPort Culture Suite supports FDA audits and submissions by converting paper-based SOPs or protocols into executable, reusable, version-controlled workflows. Each time a workflow is executed in the platform, the version of the workflow used and the data it collected is stored as part of an audit trail, which includes barcodes entries to enable full traceability of equipment and materials and reduce manual transcription errors.

Summary

The CellPort Software low code SaaS platform provides a flexible and extensible framework that spans research, GLP, and GMP settings, and enables the rapid adaptation of laboratory workflows in the process development phase with secure and compliant transfer of the technology and protocols to a GMP bioprocess setting.

Enabling traceability, transparency, and transferability to the cell manufacturing process, CellPort Culture Suite has demonstrated proven success in supporting FDA submissions and was shown to have a major impact on the speed and outcome of routine FDA audits.

Why it Matters for You

A successful commercial scale bioprocess model starts with a digitally connected laboratory. Automating, standardizing, and optimizing the R&D process, beginning with early stage research, enables digital reproducibility that can be carried all the way through downstream manufacturing. In this blog we discuss how to bridge the cell culture manufacturing gap in the following ways:

• Standardizing operating procedures across the R&D process creates the predictability necessary for cell and gene therapy development and manufacturing by managing the major sources of variation in assay execution.
• CellPort Cell Culture Suite supports the elicitation and definition of R&D, GLP and GMP assays and their execution, monitoring, reporting and compliance.
• CellPort Software has industry proven acceptance by the FDA and MHRA regulatory agencies.
• CellPort Cell Culture Suite enables cell culture models for replacing human bioequivalent testing, IND drug transport studies, and GMP potency assay release testing.

CellPort Software On-Demand Webcast

Digital Transformation of Cell Culture, Cell Manufacturing, and Cell Banking

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face. Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post NextGen Bioprocess for Cell and Gene Therapy appeared first on Astrix.

For example, how do you get your balance to talk to your network? Ask it to weigh in? Or your pH meter? Ask it for basic information? If only it were that easy.

To make the digital dream a reality, a new paradigm is needed – a platform that creates workflows on the fly by connecting the constellation of:

• Lab equipment, such as balances and pH meters
• Instruments, like chromatographs, spectrophotometers, and plate readers
• Software, including data acquisition and reporting systems, LIMS, and electronic lab notebooks

Because labs have purchased products from different manufacturers over time, this architecture also must be vendor-agnostic regarding communication protocols, and file formats. It must seamlessly integrate everything so scientists can translate data from these different sources into knowledge that enables them to make better, faster, more informed decisions to meet their objectives.

You may think this is a nearly impossible set of criteria to meet. These obstacles were insurmountable in the past. But today, those hurdles of the past are being eliminated — Scitara is making sure of that! Scitara’s mantra is “No instrument or application left behind. We haven’t encountered an instrument or application that couldn’t be quickly added to our digital backbone and we don’t think we ever will, says Geoff Gerhardt, Chief Technology Officer for Scitara.”

Scitara was founded with the singular goal of providing products and services that help labs implement a truly cohesive, comprehensive, and secure digital ecosystem. Their Scientific Integration Platform SIP, with its Digital Lab Exchange DLX engine, breaks down entrenched data silos by connecting, orchestrating, and monitoring every piece of hardware on your benches – even those that do not have a communication port – and software that resides on your computers, servers, or the cloud.

Scitara DLX was developed by scientists like you who understand your needs. “We knew it had to be flexible and scalable so it can grow as your needs evolve, says Gerhardt. We knew it had to work with your existing systems and be easy to deploy and configure. And we knew it had to ensure accurate, properly structured data models that could be used to feed artificial intelligence and machine learning systems.”

Scitara’s innovative solution to the lab connectivity challenge will enable your lab with:

• Increased efficiency and productivity
• Simplified workflows with dashboards for easy monitoring
• 360-degree view of the lab at any time for real-time monitoring of system and workflow status to optimize uptime
• Reduced risk with enhanced data integrity and full audit trails

Scitara’s solutions are powering the digital transformation of scientific laboratories. By enabling them with modern lab data connectivity infrastructure and tools to accelerate science, the integration of existing and new instruments and application into the lab ecosystem has been greatly simplified, eliminating downtime and significantly reducing operational costs.

Why It Matters to You:

Scitara’s solutions are powering the digital transformation of scientific laboratories by enabling them with modern lab data connectivity infrastructure and tools to accelerate science. Their Scientific Integration Platform SIP solves the lab connectivity challenge by enabling your lab with:

• Increased efficiency and productivity
• Simplified integration of existing and new instruments and applications onto the existing lab architecture (e.g., LIMS)
• Streamlined workflows with dashboards for easy monitoring
• 360-degree view of the lab at any time for real-time monitoring of system and workflow status to optimize uptime
• Reduced risk with enhanced data integrity and full audit trails
• Decreased total cost of ownership

About Astrix and Scitara:

Astrix in partnership with Scitara offers innovative solutions for all of your laboratory informatics needs, enabling the lab of the future. Before you take the next step in your digital journey, explore how Astrix in partnership with Scitara are transforming the way science-based business succeed today by visiting astrixinc.com.

Scitara is a global provider of cloud-based, industry-specific platforms and solutions for the life sciences industry. Based in Massachusetts, the Scitara leadership brings decades of experience in solving digital challenges for the scientific laboratory: Meet the Modern Lab. For more information, please visit scitara.com.

The post Solving the Unsolvable: Enabling the Fully Connected Digital Lab appeared first on Astrix.

Antibody by Design

The antibody drug discovery process begins with screening, target identification, characterization, and validation. While significant advances have been made in high-throughput screening technologies for biopharmaceutical discovery, the future of antibody design relies on the ability to effectively utilize predictive models for multi-parameter target evaluation and optimization.

 A necessary prerequisite for successfully deploying advanced analytics is a fully digitized and connected laboratory environment. Digital transformation holds the promise for overall process improvement and better access to data, leading to substantial gains in R&D efficiency. The biopharmaceutical industry has historically taken a cautious approach to change, and therefore digital transformation, in part due to potential risk factors and compliance burdens. Recently, these efforts have been gaining momentum with the promise of accelerating scientific innovation, however, the complexities of digitally transforming the biopharmaceutical laboratory and lack of robust commercially available tools have created substantial roadblocks to progress.

A New Digital Paradigm

 Bionamic (Lund, Sweden) is changing the paradigm for antibody development. Founded by Dr. Anders Carlsson and Dr. Morten Krogh, whose combination of experiences from life science (Scripps Research and USC), theoretical physics (Princeton and CERN) and software development is fertile ground for creating the best therapeutic antibody research platform in the world.

 The idea behind Bionamic was developed while consulting at various biopharma companies, where the challenges of organizing and analyzing development data were obvious and researchers were frustrated by the inefficiencies caused by the lack of appropriate software. The central concept underpinning the Bionamic software platform is the integration of the multiple types of biopharmaceutical data within your laboratory ecosystem, including LIMS and ELN, to fully digitize your antibody discovery and development process.

Bioinformatics lies at the core of the development of biological therapeutics. Common but complex questions involving antibodies, their targets, history and performance can be answered through a network of biological relations that connect your data using Bionamic’s powerful search functionality.

Your antibody data is stored as an audit trail and every change is traceable to who, what, and when – including deletions. Once entered, your data is securely stored in the cloud and will always be available and recoverable.

Summary

 Bionamic’s cloud-hosted software platform (SaaS) is designed to trace, analyze and validate antibody sequence and assay data using key structures and relations based upon true biologic and physical concepts providing the digital continuity needed to modernize antibody development and eliminate the barriers to achieving digital transformation in biopharma R&D.

Why it Matters for You

The future of antibody design relies on the ability to effectively utilize predictive models for multi-parameter target evaluation and optimization, requiring digital continuity within the laboratory environment which can be a frustrating challenge within biopharma R&D. Bionamic is accelerating scientific innovation by changing the paradigm for the digitalization of antibody development in the following ways:

• Bionamic’s cloud-hosted software platform (SaaS) is designed to trace, analyze and validate antibody sequence and assay data using key structures and relations based upon true biologic and physical concepts.
• The Bionamic software platform integrates multiple types of biopharmaceutical data within your laboratory ecosystem, including full integration with LIMS and ELN, modernize antibody development and eliminate the barriers to achieving digital transformation in biopharma R&D.
• State-of-the-art data encryption and storage allows instant access and secure collaboration across multiple sites in a compliant framework.

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation & 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 outcomes to help people everywhere.

The post Antibody by Design: Digital Transformation Advances Biopharma R&D appeared first on Astrix.

Digitalization of the laboratory is essential for organizations to maintain a competitive advantage in today’s fast-paced business landscape. As the digital transformation movement is gaining enormous momentum, companies across all industries are adopting a ‘digital-first’ business model. However, just moving our systems away from paper is not enough to call ourselves ‘digitized’ or claim ‘digital victory’.

The true benefit of digital transformation focuses more on the transformative nature of this effort than on the digital aspects. Gains in efficiency resulting from automation translate into faster time to market and cost savings, while digitalization can improve data quality and expedite access to aggregated, contextualized data. As “cloud-first” has now almost become synonymous with “digital-first”, this has not only opened the door to a wealth of technologies enabling scalable IT infrastructure but also leveraging transformative applications such as AI and ML to support advanced analytics and predictive modeling.

Upcoming Webcast with Digital Lab Consulting:

“Putting in Place the Foundations for Successful Digital Transformation?

• Date:  October 7th 1:00 EST
• Presenter: Dr. Eliot Randle, Co-founder, Digital Lab Consulting 

Strategic Roadmap Leads to Transformative Results

As most organizations move full steam ahead towards implementing a digital transformation program, many will underestimate the complexity involved in a project of this magnitude. The underlying challenges reach far back into the deployment of legacy systems and the impact that will have on the approach moving forward.

The implementation of laboratory information systems have generally been driven in a bottoms-up “transactional” manner: CDS, LIMS, ELN, LES, etc. have been deployed to deliver specific capabilities in an organic fashion. As those implementations mount, there are several significant implications, including:

• Overlaps among the systems become critical factors in the quality of information produced and the ability to determine a single point of truth.
• Obtaining an end-to-end picture of the data from a scientific process requires significant depth of knowledge in and access to many systems.
• Modifying or extending the processes served by the constituent systems becomes more and more challenging.

At the same time, there are significant business drivers that put additional pressure on laboratory information, some of which are:

• Handling of increasingly diverse drug products
• Meeting the increasing need for the R&D organization to be flexible and responsive
• Improving the systematic management of product data and processes where data consistency and availability are critical

This current state leads to a need for a comprehensive view of laboratory data. Through an increased understanding of the current state, a digital transformation roadmap can be developed outlining opportunities and approaches to achieving a holistic digital strategy for the lab, one that encompasses the relationships between systems and the lifecycle of data. With the diversity of laboratory equipment and the general state of information management present in most laboratories today, an analysis of the current state environment leading to the development of a strategic informatics roadmap is essential for achieving a successful digital transformation.

Transforming Businesses Through a Better Use of Informatics

Significant investments are being made in digital transformation by organizations throughout the globe and across all industries. In a recent study by Forbes, companies that earn $1 billion per year earn an additional $700 million over three years by investing in the customer experience through digital transformation. The report goes on to state that 56% of CEO’s have indicated that digital improvement had led to increased revenue, with digitally mature companies being at least 23% more profitable and 64% more likely to achieve their business goals than their less mature peers. As the digital timeline progresses, 68% of global business leader believe that future of business involves humans and AI working together.

While there are measurable benefits resulting from a successful digital transformation, what is the actual cost of failure in this effort? Statistics show that as much as 50% of digital transformation efforts ‘fizzled out’ completely while 55% of companies that are lacking a digital transformation strategy believe they have less than a year before they start to lose market share.

The common reasons for failed digital transformation initiatives are not having the right culture in place, lack of strategic direction and lack of expertise and resources needed to manage and drive the program towards a successful completion. A failed digital transformation is not the end of the road but can be extremely costly in terms of the lost time, money, resources and overall impact on the company due to this unsuccessful effort.

Digital Lab Consulting is an independent strategic consulting company that enables organizations to transform their business through better use of technology, removing the risk associated with complex informatics projects. With over 20 years of experience spanning early research to manufacturing and covering a wide range of technologies across the entire value chain, Digital Lab Consulting provides clear, actionable advice to help companies find the most effective solution for their environment and develop a successful digital transformation strategy.

Summary

Partnering with expert informatics consultants from the outset of your digital transformation program will not only save your organization money by keeping the program on budget but will also help you to minimize risk by avoiding the statistically significant failure points outlined above that cause digital transformation programs to fall short of expectation or fail entirely.

Astrix’s alliance with Digital Lab Consulting is extending our reach of expertise into the European market. Together, we provide the technical, strategic, regulatory and content knowledge to deliver 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.

Why it Matters for You

Digitalization has the potential to dramatically transform your business with the right approach. However, digital transformation initiatives are often far more complex than expected, with a high risk of failure if not properly planned and deployed. Following industry best practices will lead to a establishing a successful digital strategy within your company:

• Developing a robust strategic informatics roadmap is an essential element of a successful digital transformation program and requires a thorough analysis of the current state environment before embarking on the future state program.
• Using a vendor independent approach to developing, planning and implementing your digital strategy can provide the best informatics solution that is tailored to your specific business needs.
• Partnering with Digital Lab Consulting 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 through a better use of technology and maximize the benefits that you will gain from digital transformation.

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation & 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 outcomes to help people everywhere.

The post Why Take the Risk? The Benefits of Expert Strategic Consulting appeared first on Astrix.

Article Excerpt Featuring Dave Dorsett,  Astrix Principal Software Engineer

Determining the best approach to a digital transformation effort can be a confusing and complex task for most organisations, suggests Dave Dorsett, principal software architect at information technology consultancy, Astrix. ‘No single approach exists to transport you from a current state of paper processes, siloed technologies and inconsistent data sets to the digitally transformed laboratory of the future. The reality is the digitisation journey will be different for everyone, based upon the unique set of circumstances surrounding your business.’ However, three pillars build the foundation for all successful digital transformation initiatives: people, process and technology.

Think of the example of a three-legged stool, he continues. All three legs must be present and solid for the stool to provide support and its intended function for long-term use. ‘The most important ‘leg’ (or pillar) for the support and sustainability of your digital transformation strategy is people. Having the right leadership in place is absolutely critical to providing a culture of innovation to foster the dramatic change that will take place in your organisation. The people within your organisation are essential not only to carrying out the effort itself, but also must embrace the changes that will continue to drive your digital transformation strategy.

The second pillar, process, is the biggest single tool necessary for digital transformation. Achieving practical process analysis to support digital transformation means keeping your eye on the goal, not on the process itself, Dorsett maintains. ‘Basic operational process improvement opportunities are likely to be found across the organisation, and include the elimination of the manual entry of data and automating what people are doing repeatedly. Before embarking down the path to directly eliminate these practices, take the time to determine what people are doing before and after. The key to creating a truly transformative environment is to develop a roadmap of your ‘as is’ and ‘to be’ future-state scientific processes, then mapping out the data from end to end.’

The third and final pillar of a successful digital transformation strategy is technology. Perhaps one of the most commonly misunderstood elements of digital transformation programs is the tendency to focus on the operational systems within the laboratory: LIMS, ELN, CDS and SDMS, to name a few. ‘The goal is to address the data created and consumed by the organisation, not to implement systems per se,’ Dorsett stresses. ‘It is not a ‘buy and deploy it’ project: no vendor sells what is required to operate as a data-driven organisation.’

Accessibility of data is, Dorsett continues, ‘everything!’ Achieving a state of ‘analytics-ready’ is about R&D data flow throughout every aspect of your operations. ‘Siloed technologies and manual processes impede the flow and accessibility of data. Achieving seamless R&D data flow also has cultural requirements (data governance) and technical requirements (semantic tooling).’

Exponential growth in R&D data has, in addition, generated immense interest in whether and how R&D data may be used more effectively. ‘Efforts to become data-centric to enable ‘running with algorithms’ and the use of artificial intelligence (AI) and machine learning (ML) for predictive purposes have become commonplace.’

Read the full article here: Scientific Computing World,  Summer 2021 issue

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 outcomes to help people everywhere.

The post Scientific Computing World Article: A Digital Journey appeared first on Astrix.

The Internet of Things (IoT) has provided the pivotal launch point for today’s Digital Revolution. The network of sensor enabled technology is connecting the universe in unimaginable ways from SMART personal devices to automated technology powered by artificial intelligence to gather information from the surrounding environment. As use cases for this disruptive technology continue to evolve, a decades old concept gains new life, the ‘Digital Twin’.

The post Digital Twins Catalyze the Lab’s Digital Revolution appeared first on Astrix.

Digital transformation has become a top priority for most organizations with efforts currently underway regardless of industry. Paper-based approaches giving way to digitized solutions, the automation of manual processes to improve efficiency, and tech-enabled systems provide intelligent applications leading to ‘success through data’.

While the flurry of digital activity has become business as usual for many organizations, the clinical laboratory remains challenged by two crucial requirements to realize the value gained from migration to a truly digital world: managing patient data in proprietary formats and tracking the chain of custody while maintaining the integrity of specimens throughout its lifecycle. The outdated workflows present in today’s clinical laboratories prevent the progress of digitization and their ability to deliver secure, timely, accurate, and cost-effective pathology services.

Compliance Considerations for Clinical Digital Transformation

Anatomical pathology (AP) labs are largely run on a multiplexed universe of manual process. Tracking specimens in a secure and compliant framework while maintaining chain of custody records is as arduous task for most laboratories and in clinical settings, with significant consequences for errors occurring throughout the process.

The AP industry is heavily regulated, requiring strict adherence to extensive compliance measures under CLIA, CAP, FDA and HIPAA guidelines. Each year, the quantity and frequency of regulations governing clinical testing is increasing, with a new regulation or modifications to existing regulations occurring nearly every week. Furthermore, under federal law, AP is classified as “high complexity” testing. CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) regulations governing these labs require that certain educational and training qualifications for laboratory personnel have been met and properly documented along with scientifically endorsed accreditations to ensure that laboratory standards meet or exceed CLIA requirements.

Conversely, while regulation is increasing by leaps and bounds, reimbursements for professional AP services are decreasing by an even higher margin: 35% decrease in 2018, leading up to an additional 8% average decrease in 2021. This creates additional burden on pathology practices to obtain and manage additional repayment options through hospitals and clinics, ultimately driving up operational costs.

The management of records, documentation, and reporting that is critical to support compliance standards and facilitate audit requirements within an AP practice far exceeds their ability to cost effectively manage the process within a setting of manual operating procedures, necessitating a new business model to remain competitive in the marketplace.

Perfect the Workflow, Perfect the Business

The demands of the current regulatory landscape have created a huge opportunity for improving operational efficiency and, therefore, profitability for AP practices through better integration and digitally automated workflows. Cerebrum, a leader in Laboratory Information Management Systems (LIMS), offers intelligent lab workflow software solutions for medical and life sciences pathology labs, focusing on improving patient safety, regulatory compliance, and lab efficiencies. Their mission is to enable pathology lab professionals to perfect their businesses by perfecting their workflows for all types of patient specimens at busy, growing practices.

Cerebrum’s LABdivus^® software platform provides a cloud-based digitized workflow solution for AP labs and CRO’s to automate their operations to increase productivity and avoid the risk of error by accurately tracking specimens from accessioning through reporting. The core application features that will allow you to achieve and maintain your CLIA/CAP/FDA compliancy while effectively managing the workflow of your growing lab include:

• Specimen Tracking: Comprehensive and accurate specimen tracking is of utmost importance in a highly regulated environment. Knowing what specimens are in the work queue, where they are and who handled them provides valuable real-time information as well as an imperative historical perspective.
• Compliance Integration: With LABdivus SOP, workflow tracking and reporting, your operation will avoid compliance issues and shutdowns. Password protection, two-factor authentication and administrative-designated user restrictions provide a level of security that is fully CLIA, CAP and FDA compliant.
• Pathologist Diagnosis Reporting: Quick access to patient data, both past and present, allows for greater efficiency in reporting out a case. Pathologists have complete control over diagnosis and CPT codes, microscopic descriptions and additional commentary needed for the technical components.
• Lab Insights: See your lab operation’s work volume at every workflow step. Report on lab tech throughput, turn-around-time, completed diagnosis reports and specialized reports such as cancer reports and high-profile diagnosis reports.
• EMR Connectivity: Connect your lab data workflow to electronic medical record (EMR) and other systems. LABdivus includes HL7 and other customizable interface protocols to integrate with your practice management, billing, and insurance systems. Eliminate redundant data entry, human error, and efficiently automate inbound and outbound information.

Summary

Automating your AP workflow with LABdivus will alleviate bottlenecks in accessioning and specimen tracking and provide a higher level of confidence in the data associated with your specimens to avoid compliance issues and potential regulatory shutdowns. By transforming outdated manual workflows to digitized seamless processes, pathologists can realize 4X efficiency gains to allow your lab to remain competitive in the marketplace, even in the face of ever-changing regulatory and cost reduction measures, while positioning your business for future growth.

Why it Matters for You

While digital transformation has become a top priority for most organizations, the clinical laboratory remains challenged by two crucial requirements to realize the value gained from migration to a truly digital world: managing patient data in proprietary formats and tracking the chain of custody while maintaining the integrity of specimens throughout its lifecycle. Implementing the following solutions will allow you to seamlessly digitize your clinical laboratory to achieve gains in operational efficiency:

• Knowing what specimens are in the work queue, where they are and who handled them provides valuable real-time information as well as an imperative historical perspective, critical for chain of custody tracking in a highly regulated AP environment.
• Having quick access to past and present patient data, diagnosis and CPT codes, and microscopic descriptions, increases pathologist’s efficiency in reporting out a case and detailing its technical components.
• Connecting your lab data workflow to EMRs and other systems through HL7 or API interface protocols will integrate with your practice management, billing and insurance systems to eliminate redundant data entry, and human error that can occur during data transfer.
• Using Cerebrum’s LABdivus^® cloud-based software platform in your AP lab will automate your operations and increase productivity while providing a level of security that is fully CLIA, CAP and FDA compliant.
• Perfecting your workflows will enable you to perfect your business!

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.

The post Intelligent Workflows: Digitizing Today’s Clinical Laboratory appeared first on Astrix.

Formulation development is of critical importance in the research & development (R&D) lifecycle of a product. However, many organizations are struggling to manage the complexity of data arising from the modern formulation process. Advanced analytics powered by artificial intelligence (AI) hold the potential to predict new formulation performance, provide optimized experimental recommendations and accelerate innovation. Without an effective data-centric digitization strategy in place, these transformative tools remain just out of reach.

Uncountable helps R&D scientists move from isolated spreadsheets and projects to a comprehensive data management system the whole team can work in. Using the latest predictive technology built on secure, cloud-based infrastructure, you can develop innovative products without the hurdles and inefficiencies of yesterday.

Synchronized R&D Transforms Product Development

Whether working in a polymer synthesis, cosmetics development, pharmaceutical formulation, or a paint and coatings lab, the practical data workflows and statistical platforms surrounding formulation development are all quite similar. Preformulation testing, the first stage of the process, involves the analysis of the physical and chemical properties of the ingredients for analytical methods development, including the evaluation and QC testing of raw materials. The second stage of the process, formulation, requires extensively testing the combinations of a wide variety of ingredients to achieve the desired characteristics of the final product.

This multilayered process will typically involve testing 5 to 25 substances that may go into a product, with as many as 30 different parameters being measured for the product itself. As many as 90% of materials science and biotech companies are using Excel and laboratory notebooks to manage these processes, creating data siloes that prevent digitization, automation, and the aggregation of data required for predictive formulation data modeling and leveraging cross-project learnings.

The complexities of a data centralization strategy are common across both materials science and biotech, where ‘out of the box’ and ‘homebrew’ systems do not provide scientists and formulators viable solutions to how their data is presented and shared amongst the teams. From raw material lot tracing to compound mixing and final product performance, there is a lot of information to capture effectively.

Uncountable is creating the future of scientific product development with an AI-powered platform for innovative R&D workflows. By leveraging advanced artificial intelligence techniques, Uncountable augments the traditional R&D approach to get better products to the market in half the time.

“We need a way to quickly and easily synthesize all that information so that we are flexible enough to cover all of those use cases, but streamlined enough that each step is fluid, easy and responsive for the scientist, tailored to their specific workflow.” – Will Tashman, Founder, Uncountable

Uncountable’s data platform enables collaboration, knowledge management and faster development of products. Scientists can use the platform to store, visualize and analyze critical experiment data from raw ingredients and different suppliers to experimental results. Advanced machine learning models that are layered into this unique platform allows scientists to predict how new formulations perform, and uncover new relationships that they might not have recognized because the analysis is streamlined and surfaces in an intuitive way.

Summary

The successful digital transformation of the modern laboratory centers upon solving the complex product development challenges and the ability to effectively harness the vast amount of experimental data collected. As labs start to automate processes and collect data across workflows in hopes of creating a predictive engine to accelerate product development, many scientists remain working out of spreadsheets due to the lack of cohesive informatics solutions that meet the specific needs of the laboratory.

Uncountable is a true partner to R&D teams, providing the right platform for easy integration into scientists’ current workflows to improve knowledge management and uncover new development opportunities. Uncountable’s proprietary machine learning algorithms have been tailored to the complex data environment of scientific experimentation so that you can streamline your data, share key insights across teams and speed innovation to outpace the competition by learning more from each experiment you run.

The Uncountable platform provides a landscape that’s flexible enough to handle the data, but is also a collaborate platform that allows you to uncover new learning that you couldn’t otherwise find in very siloed work environments. Streamlining your workflow while removing the data handoff points and formatting issues enables scientists to move faster, experiment more efficiently, and ultimately make better products. The AI tools that are built into the platform help scientists predict how new formulations will perform, transforming their digitalization effort as they move to a more effective and efficient platform for creating products, thereby accelerating the R&D process.

Why it Matters for You

Scientists are tasked with solving complex product development challenges without the ability to harness the vast amounts of experimental data collected. This results in siloed data and inefficient processes that hinder innovation, ultimately delaying time to market. The fastest path to the best product involves rethinking the way you manage scientific development in the following ways:

• Implementing the Uncountable software platform enables R&D scientists to move from isolated spreadsheets and projects to a comprehensive data management system that allows for seamless collaboration and utilization of the latest predictive technology so you can develop innovative products without the hurdles and inefficiencies of yesterday.
• Creating the best data possible can be achieved by planning out your data strategy to maximize R&D resources using Uncountable’s platform to provide the data structure required to be successful in modeling formulation problems effectively while keeping ease-of-use front and center.
• Using AI visualization tools will unearth new learning and add predictive capabilities to your R&D toolset to accelerate development.

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.

The post Digitalization and the Future of Formulating in Modern R&D Labs appeared first on Astrix.

With the legalization of both adult recreational and medical cannabis in a variety of states, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug/product potency. Growing numbers of laboratories that specialize in evaluating cannabis and cannabis products are emerging to fill this niche. Typical lab testing on cannabis botanical samples includes:

• Potency
• Terpenes
• Strain (terpene/cannabinoid ratios)
• Residual solvents
• Pesticides
• Heavy metals
• Water activity
• Moisture content
• Foreign materials
• Mold and microbiological contaminants

Cannabis testing labs typically receive high volumes of test requests from cannabis growers and/or cannabis product manufacturers, and these labs need to develop effective data management strategies to stay competitive and maintain regulatory compliance. Using manual, paper-based methods (e.g., spreadsheets, notebooks, etc.) to gather, organize and control laboratory testing data is error-prone and time-consuming, especially as testing volume increases.

A Laboratory Information Management System (LIMS) is a software tool that allows for efficient data management and laboratory operation. LIMS can help to ensure regulatory compliance and provide the accurate and speedy results, reports, and certificate of analyses (COA) that are required for cost-effective operation in today’s highly competitive cannabis testing market. In this blog, we will discuss some LIMS features that can benefit cannabis testing laboratories, along with best practices for ensuring a successful LIMS implementation in your lab.

LIMS Features and Functions

Cannabis testing labs have to be able to stay in sync with the rapidly evolving regulatory requirements in this new and fast-growing industry. These labs also need to be able to operate cost-effectively and provide accurate and timely results to maintain competitiveness. LIMS provides a single, centralized database for all testing data, enabling effective data management and accessibility, along with a defendable quality assurance/control (QA/QC) framework to meet regulatory compliance.

LIMS provides data security and traceability from the moment a sample arrives in the lab, all the way through to final reporting and disposal. The LIMS tracks all testing data and parameters tested, along with corresponding test methods and paperwork (converted to PDF format) associated with the work order.

LIMS can track and manage other laboratory data as well to help ensure quality is maintained and operations run smoothly. For example, LIMS can be utilized to track reagent and supply expirations, incubator and freezer temperatures, instrument calibrations and employee training schedules and/or status.

A few of the many useful features and functions that LIMS can provide to cannabis testing labs include:

• Sample and split-sample tracking, allowing for an accurate chain of custody
• Positive ID (RFID, barcoding) from login to final disposition
• Chemicals, reagents, standards and supply inventory, order management and tracking
• Equipment management – maintenance and calibration schedules tracked
• Manual or automated (via instrument integration) data entry/transfer
• Stability testing modules
• Document management – method versioning, SOPs, manuals, etc.
• Resource management – instrument records, employee training records, etc.
• Workflow management – promotes better workflow efficiency and resource allocation
• Records comprehensive audit logs for laboratory activities along with the date and time stamp
• Data security and confidentiality – masks sensitive data from unauthorized user access
• Quoting and invoicing
• Integration with industry (e.g., seed-to-sale software, dispensary software, etc.) and enterprise (e.g., ERP, etc.) solutions for efficient data transfer, regulatory compliance and seamless accounting
• Automated and real-time reporting via export to a web portal or email
• Integrated web portal for 24/7 result access, sample submission, and locked report downloads
• Support for regulatory compliance and/or accreditations – ISO/IEC 17025, ISO 9001:2015, GLP, 21 CFR part 11, etc.

LIMS Implementation Methodology

Selecting, implementing and integrating a LIMS solution can be a challenging endeavor. In fact, nearly half of LIMS projects fail to meet one of more of the following metrics:

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

In order to ensure success, a comprehensive and proven methodology should be followed. This methodology should include strategic planning that leverages a workflow and business analysis to generate a set of optimized future-state requirements that will maximize business value for your organization. Instead of trying to implement a LIMS based only on your current workflows, why not implement your project in a way that optimizes your business? Without a clear strategic plan, companies often implement solutions in ways that do not support the business’s future goals.

Once a set of optimized future-state requirements are generated, it is time to select the LIMS that is the best fit for your system requirements. Care should be taken to choose the optimum hosting solution for your LIMS, which for cannabis labs is often a cloud-based system. Given that there are several LIMS options now on the market that are specifically designed for the cannabis industry, the selection process should be sure to include these vendors in the evaluation. Whatever system is chosen should be highly adaptable to enable staying in sync with the rapidly evolving regulatory requirements in this industry.

Finally, the project team should have significant technology expertise and experience designing, implementing and integrating complex solutions in a validated environment.

Conclusion

Given the highly competitive and rapidly changing nature of the cannabis industry, a LIMS is a necessity for high volume cannabis labs. In addition to reducing manual workloads and enhancing operational efficiency, a LIMS supports effective data management and security, along with regulatory compliance.

Astrix Technology Group has over 20 years of experience facilitating success in LIMS implementation projects. Since 1995, our professionals have successfully applied best practices in the evaluation of work processes, functional and technical requirements, laboratory processes and LIMS solution options for hundreds of clients and tens of thousands of scientists in a wide range of industries. Our exposure to hundreds of customer initiatives and expertise with many different LIMS allows for an enhanced understanding of what might be possible to optimize your laboratory environment.

The post Benefits and Best Practices for LIMS Implementation in Cannabis Testing Labs appeared first on Astrix.

The challenges surrounding big data management are common across the biopharmaceutical industry: siloed data preventing the flow of information, manual processes limiting productivity, error-prone data transcription, and heterogeneous data formats, all rendering valuable R&D data inaccessible and not re-usable. Due to the varied scope of work being conducted and the breadth of laboratory instrumentation and systems throughout their digital landscape, it is not surprising that a siloed and fragmented ecosystem exists in most biopharma organizations, creating an enormous roadblock to scientific innovation.

Solving the Big Data Challenge

The digital lab is powered by free-flowing, harmonized data across the global reach of biopharma organizations. Data-centric enabling technologies such as artificial intelligence (AI) and machine learning (ML) require accessible, clean, and harmonized data to provide accurate predictive models to accelerate R&D.

Point to point integrations, which are the current standard for lab connectivity, do not facilitate a fully digitized lab environment. They create islands of disconnected data lakes, are highly customized and/or difficult to maintain, and prevent the free flow of R&D data necessary for advanced analytics. Many commercially available out of the box ‘solutions’ only focus on automated and centralized data collection, which does not address the critical issue of data harmonization.

TetraScience’s cloud platform provides the central hub that enables the free flow of harmonized digital data across all systems and workflows surrounding your R&D lifecycle. The Tetra R&D Data Cloud combines the industry’s only cloud-native data platform built for global biopharma companies with a diverse array of connections to common R&D data systems and informatics. Lab connectivity is achieved through an open, configurable, API-driven and vendor-agnostic data cloud which allows you to connect to existing heterogeneous and best-of-breed data solutions while re-platforming to the cloud.

TetraScience Platform Integrations with Data Targets

Leveraging the power of AWS, the Tetra R&D Data Cloud engages with a wide array of laboratory systems via the TetraScience connector library to move source data over to the cloud and into the Tetra data lake, where it becomes centralized but not yet harmonized. The data pipeline is then converted into a standardized data format by the Intermediate Data Schema (IDS) and prepared for transfer to your laboratory’s ecosystem of downstream applications. This approach solves all of the big data challeges faced by biopharma organizations to provide automated, centralized and harmonized data essential for advanced analytics.

Summary

TetraScience provides biopharma companies with the flexibility, scalability, and data-centric capabilities to easily access centralized, standardized, and actionable scientific data. As an open platform, TetraScience has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, visualization, and data science partners, creating seamless interoperability and an innovation feedback loop that will accelerate discovery by empowering digital transformation to drive the future of biopharma R&D.

Why it Matters for You

The digital lab landscape of today’s global biopharma organizations is largely comprised of siloed and fragmented data that hinders gaining actionable insights quickly and efficiently. These common challenges with big data can be solved in the following ways to achieve operational excellence across all scientific laboratories operating across your R&D lifecycle:

• Harmonizing data across the global reach of your biopharma organization will allow for the free flow of data that powers the digital laboratory and drives AI/ML technologies to accelerate R&D.
• Deploying a data management platform with a scalable cloud infrastructure and resilient universal connectivity provides automated, centralized and harmonized data essential for advanced analytics.
• Implementing the Tetra R&D Data Cloud allow you to manage R&D data as your core asset, enabling advanced data-centric capabilities to automate the full life cycle of R&D data. TetraScience’s open, API-driven, vendor-agnostic platform provides the freedom of choice to connect existing heterogeneous systems and best-of-breed data solutions, while re-platforming to the cloud.

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.

The post Unlock Discovery with Harmonized Data in the Cloud appeared first on Astrix.