When it comes to computer system validation (CSV), organizations face several challenges when trying to meet critical regulatory requirements. This blog post will explore six of the most common challenges and provide tips on overcoming them.

CSV is a complex standard that can be costly and time-consuming to implement, particularly if you’re validating on paper. However, by adopting a risk-based approach, you can determine the appropriate level of testing and documentation required to meet regulatory expectations. If a system is deemed low to medium risk, Computer Software Assurance (CSA), a simplified method for performing CSV, can reduce project costs and accelerate time to market. Unfortunately, if you’re validating on paper, any potential efficiency gains from CSA will be lost.

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“How to Manage Logbooks Electronically – From Paper to Cloud”

• Date: October 27, 2022, 1:00 EST
• Presenter:  Sophia Vraka, Sr. Engineer Industry Solutions, ValGenesis

The high cost of paper-based CSV

To understand why drug and medical device manufacturers spend so much time on CSV, you must first recognize its many challenges. If you’re dealing with any of the following challenges, it’s time to digitize your CSV files:

1. Strict regulatory requirements:The FDA, under 21 CFR Part 11, and other global regulatory agencies require all computer systems operating in regulated environments that come into contact with a product during its manufacturing, testing, or distribution, to be validated to ensure product safety and effectiveness.
2. Burden on internal resources:Manual CSV processes require tremendous personnel hours in terms of routing documents, obtaining signatures and approvals, recreating lost documents, and searching and retrieving paper files during audits and inspections. Staff members are pulled from their primary duties to perform repetitive tasks, which can quickly become frustrating or annoying.
3. Inconsistent vendor quality practices:Many life sciences companies use various configurable “off-the-shelf” software systems, such as a document management system (DMS) or a quality management system (QMS). The manufacturers of these solutions often have limited knowledge of regulatory requirements and may not provide tools or services to support CSV efforts.
4. Maintaining compliance:CSV is an ongoing process. Requirements must be continuously updated throughout the lifecycle of the software system. Proper procedures must be established for change control, system maintenance, and managing system releases. The pace of technological change combined with ever-changing manufacturing processes makes this virtually impossible with manual validation.
5. Risk vs. cost:Insufficient validation poses a non-compliance risk; however, over-validation (e.g., over-testing and over-documenting) is equally undesirable. Over-validation leads to wasted time and resources, delayed production schedules, and unnecessary financial expenses. In fact, over-validation is what prompted the FDA to develop CSA as an alternative to CSV. Manual validation methods complicate this further because they lack uniform tools and methods for conducting consistent risk analyses.
6. Delayed time to market:Paper-based validation processes stifle innovation and compromise an organization’s ability to bring products to market on time.

CSV of the Future – Let’s Get Rid of the Paper!

The pharmaceutical and biotech industries are under pressure to keep pace with the latest technological advancements and comply with an increasing number of regulatory requirements. To stay competitive and meet these demands, these industries must move away from paper-based CSV methods and embrace digitalization efforts.

However, many of these efforts stall when confronted with the traditional CSV methodology. This is where ValGenesis VLMS comes in –the pioneers of paperless validation. The industry’s first, proven, 100% paperless validation lifecycle management solution delivers technology solutions that are validated, fully configurable, and rapidly deployable through a validated private secured Cloud. This enables new levels of collaboration throughout the organization while improving efficiency and compliance.

The Benefits of Automating your CSV Processes

Eliminating paper from your validation process will allow your organization to gain the full spectrum of benefits from your digital transformation program. ValGenesis provides the tools you need for success in the Lab of the Future.

Why it Matters for You

As laboratories undergo digital transformation, the need for efficient and compliant validation processes becomes more critical than ever. A big challenge to overcome in this process is the reliance on paper-based methods.

In this blog, we discuss the following:

• What makes paper-based Computer System Validation so challenging.
• The benefits of digitizing your CSV process: Improved regulatory compliance, increased audit readiness, reduced cycle time, streamlined cross-functional collaboration, enhanced traceability, and reduced over-testing.
• How shifting to a paperless, automated validation lifecycle management system like ValGenesis can lighten your validation burden and save you considerable time, money and effort.

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, solutions, and people to the life science community. Through world-class people, process, and technology, we work with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations. To learn the latest about how Astrix is transforming the way science-based businesses succeed today, visit www.astrixinc.com.

The post 6 Common Challenges of Paper-Based computer system validation (CSV) and How to Digitize Them appeared first on Astrix.

The R&D landscape by nature is in a constant state of flux, with varying needs for instrumentation, software applications, and workflows. As a result, data can end up in silos; fragmented, unstructured, and inaccessible by other groups.

This in turn leads to poor productivity, missed observations, and flawed technology transfer across sites or scales of development.

Lab informatics solutions have relied on laboratory information systems (LIMS), electronic lab notebooks (ELNs), and the ever-present Excel spreadsheet for data management. On their own, LIMs and ELNs provide flexibility or structure, but not both. Excel spreadsheets are a major source of human error in data aggregation and not scalable for analysis of large data sets.

The industry needs an optimal data solution tailored to the modern, agile R&D laboratory. This solution must be flexible, structured, and capable of contextualizing and automatically formatting data for interactive analysis such as machine learning and visualization.

Bulldozing Data Silos Clear the Path for Scientific Innovation

Riffyn clears the path for scientific innovation by addressing problems around scientific experimentation and data analytics in the modern R&D laboratory with Riffyn Nexus, the world’s first cloud-based Process Data System.

By placing R&D workflows and processes at the center of everything, Riffyn Nexus embeds the continuous improvement principles into its architecture. It solves the workflow, collaboration, and scientific data analysis problems that have long plagued traditional LIMS, ELN, and SDMS technologies.

Principles of continuous improvement for adaptive process design, automation and analytics in laboratory R&D

Riffyn Nexus is built upon four guiding principles for continuous process improvement:

• Design – the process technology or method that you will use to deliver the result or achieve the outcome
• Measure – metrics to determine if you are actually delivering on the design specification
• Analyze and Improve – look for deviations from expectations and look for ways to improve your process
• Learn and Share – collaborative work, apply iterative process for improvements, share with teams and the organization

The continuous improvement model for adaptive process design allows you to gain insights into your data for correlative analytics while enabling the agile workflow environment required for R&D excellence.

Conclusion

Riffyn Nexus solves the data complexity of modern R&D organizations and provides the industry with the flexible, agile data management solution it needs. By putting information and data in context across experiments and workflows, it eliminates data silos and connects teams across sites and disciplines. With Riffyn Nexus, you can finally bulldoze all the silos preventing you from creating a culture of continuous improvement, building confidence in your R&D decisions, and gaining more insights from your data faster than ever before.

Why it Matters for You

Data silos create inefficiencies in productivity. Changing the informatics paradigm to a continuous improvement model for adaptive process design allows you to gain unprecedented insights into your data.

• Eliminating data silos allows users to answer questions of cause-and-effect across the traditional silos of team, place and discipline.
• Riffyn Nexus’ adaptive process design architecture enables data to be contextualized for on-demand, rich statistical analysis, visualization, and machine learning.
• The built-in versioning within Riffyn Nexus creates a continuously adapting informatics model so that laboratory methods, data, and analysis are always in sync with ever-changing R&D processes.
• Leveraging Riffyn Nexus’ modular execution framework digitally transforms R&D processes by Excel templates, and secondary databases, all while ensuring consistent and reproducible data capture across teams.

About Astrix

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

The post What are Data Silos Doing to Your Laboratory’s Productivity? appeared first on Astrix.

Science and Technology never stand still. This continuous evolution drives us towards a vast world of change and innovation at warp speed. SMART devices have become commonplace in nearly every aspect of our lives, capable of generating enormous volumes of on-demand data and enabling remote monitoring and control capabilities. In this age of increased efficiency, harnessing the power of data and technology can be a daunting task.

“Research laboratories are at the cusp of innovation, but it’s quite clear that, in many cases, their data management is many years behind. There is a lot of room for improvement, and we want to make the work of scientists easier by connecting everything in the laboratory: the data, the devices and the people.” – Simon Bungers, CEO & Co-founder, Labforward

While these technological advances build the foundation for the lab of future, one thing becomes clear; data management is still lagging years behind. The lack of a connected lab ecosystem creates siloed data and disparate systems that prevent automation, data accessibility and slow the progress of science.

Labforward solves the connectivity challenge, opening the door to a world of digital connectivity to create a seamless laboratory environment. Labforward’s integrated design concept enables users to connect all of their lab data to a centralized platform, that allows for real-time and remote electronic data capture, accessible through a simple interface. This innovative ‘lab operating system of the future’ blends the functionality of an electronic lab notebook (ELN) with the data management capabilities of a laboratory execution system (LES) across a seamless digital laboratory ecosystem.

The Laboperator lab automation platform provides the digital tools required to connect a wide diversity of equipment and applications to improve the flow of data throughout the laboratory. With the open platform design, labs can build digital workflows that incorporate multiple devices and allow for automated and manual steps. It is absolutely critical to have all components of the workflow incorporated into the digital footprint of the laboratory to automate processes and enable remote work.

The elimination of manual processes goes hand in hand with automation requirements to facilitate digital transformation within the laboratory. Each stage of your lab workflow that requires manual intervention, whether through the use of paper-based processes or arising from siloed technologies, represents a rate-limiting step in your operations. Laboratory notebooks are perhaps the last frontier of automation for the ‘old school’ scientific laboratory.

The workplace of today requires unique team dynamics, often working in remote settings. Readily accessible information for easy sharing with different members of the group can offer significant advantages foster collaboration. Labfolder is a next-generation ELN that replaces the conventional lab notebook and provides one continuous flow of information for each experiment.

The Labfolder platform allows for all data that is relevant to an experiment to be located in one place that is easily accessible and retrievable. The unified data structure documents and organizes all of the information associated with an experiment, to provide clean, accessible and workable data. Logical workflow guides can also be created to insure adherence to protocol in regulated environments or to guide new users.

Conclusion

Harnessing the power of technological advancements holds the key to creating a truly transformative environment of innovation. Digitization, automation and the elimination of data silos are principles underpinning any digital transformation effort, but can only be achieved through digital connectivity.

One of the most powerful advantages of end-to-end digital connectivity across your laboratory environment is the ability to work from any location, with global access to information from other sites, and monitor or impact research real-time remotely. Having the best-in-class digital solutions in place will support your successful digital transformation efforts to achieve and sustain this high level of operational efficiency. Labforward has created the operating system of the modern laboratory by connecting data, devices and researchers to enable the lab of the future.

Why it Matters for You

Digital connectivity across the laboratory ecosystem is essential for achieving a successful digital transformation. Creating bandwidth for the adoption of new technologies such as AI, ML and virtual reality is also essential in planning for the future state of your laboratory. When one considers the wide array of instrumentation and applications for the scientific laboratory, establishing seamless connectivity across the lab ecosystem requires a novel digital connectivity strategy.

• The lack of a connected lab ecosystem creates siloed data and disparate systems that prevent automation, data accessibility and slow the progress of science.
• Harnessing the power of technological advancements holds the key to creating a truly transformative environment of innovation, but can only be achieved through true digital connectivity.
• Implementing the Laboperator platform in your laboratory solves the connectivity challenge, opening the door to a world of digital connectivity to create a seamless laboratory environment that connects all lab data to a centralized platform and allows for real-time and remote electronic data capture.
• Replacing the traditional lab notebook with Labfolder will provide one comprehensive and continuous flow of information and data for each experiment that is readily accessible for easy sharing with teams to foster collaboration.

About Astrix

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

The post Solving the Connectivity Puzzle: The Lab Operating System of the Future appeared first on Astrix.