For over 20 years, the traditional CSV computer system validation has created mountains of paperwork to validate a new or updated system. It’s also created an overwhelming burden that prevented many companies from upgrading their complex systems. CSA – Computer Software Assurance – was introduced to relieve that burden, allowing companies to optimize validation activities by focusing on the processes that impact patient health and safety.  

There are many advantages of CSA over the traditional CSV approach. It is a more streamlined and efficient risk-based methodology that saves time, frustration, and money by: 

• Providing clarity for FDA’s guidance and methodology  
• Driving critical thinking to identify, evaluate, and control potential impact to patient safety, product quality, and data integrity  
• Focusing on the ability to leverage vendor qualification activities  
• Providing streamlined testing instead of one-size-fits all  
• Saving as much as 80% of validation costs  

 These are much needed improvements that are being welcomed by forward-thinking companies striving to improve their systems to stay competitive in today’s volatile market.  

Old Lessons Applied to Current Challenges  

In the 1930’s, Henry Ford shifted his thinking about how cars were manufactured. His industry changing assembly line focused on specific sub-components of his vehicles creating a plethora of efficiencies and quality improvements that allowed him to achieve unprecedented production goals.  

 Life science companies are now able to apply similar lessons in the context of validation. Much like the traditional car factory, the traditional CSV methodology demands extensive structure for every aspect of the system. CSA opens up new tools, templates and techniques, revised SOPs, and training to shift the focus to thinking critically rather than dogmatically. It is a dramatic shift in focus that can improve a company’s competitive edge by increasing their ability to test and adopt new business processes and systems and accelerating validation activities. 

fme Delivers the Advantages of CSA 

The fme team are life science experts that have the deep regulatory, clinical and quality experience required to integrate complex business and regulatory compliance requirements. By leveraging proven practices of previous decades, our extensive process expertise, and today’s best-in-class toolsets, we fast-track your evolution from CSV to CSA, eliminating manual, labor-intensive validation efforts and establishing a proven risk-based methodology.  

Learn More about the Advantages of CSA 

Currently there is no registration required to download fme’s Optimizing Validation through a Risk-Based Approach: Leveraging Computer Software Assurance (CSA) to learn more about CSA, and our CSA training options in online, instructor led, or a hybrid of eLearning and remote instructor coaching. We are happy to provide you with detailed information on our validation service offerings and can even tailor an approach that meets your needs and exceeds your expectations. 

In October, fme’s Director of Business Consulting David Gwyn was a featured contributor in an informative webinar with the Generis CARA Life Sciences team. He was able to share his rich experience and perspective on the value of a data-centric approach to document and information management, and outline some of the benefits that can be realized across an organization.

Generis also provided a comprehensive demo of their CARA Life Sciences Platform, and how it can improve quality, efficiency, consistency, and scalability across any organization.

Below is a summary of David’s introduction, an outline of the webinar, and a highlight video of the presentation. View the full webinar on the Generis site, and contact us with any questions you have about data-centricity or the CARA Life Sciences Platform.

Summary of Data-Centricity Introduction

David Gwyn: I’d like to speak for a few minutes on the essential concept of data-centricity. What I mean by that is how we can reshape our thinking about documents and the other entities we’re managing beyond traditional paper. Right now we all have an opportunity, and I will argue a necessity, to change the way we’re thinking about the information we’re managing and move forward into a more data-centric and data-focused approach.

I’m sure you remember the days where we would produce reams and reams of paper that we’d stack on a conference room table and ask the CEO to come in and sign the 356H. Eventually we said “Let’s digitize this, so we took our Word documents that we printed out before and turned them into PDFs. While this was a step forward, we really just took pictures of all those documents and obfuscated all the value. All the data that was there was buried in a digital version of the paper process.

There are much better solutions now that eliminate traditional challenges, and provide extensive improvement to quality, efficiency, consistency, and scalability across your entire organization. Let’s look at what’s possible.

Data-Centricity Webinar Outline

• Overview of a document-centric progress
• Impacts of document focus
• Brief History of Medicinal Product Submissions
• What is triggering the transition to digitalization of the process?
  • Regulations, data standards, compliance
  • Improve quality, efficiency, consistency
  • Enable scalability, promote quality, endure changing landscapes
• Characteristics of a data-driven approach
• Benefits of data-centric process
• Questions to ask to prepare for a transition to a data-centric approach
• Detailed demo of Generis CARA Life Sciences Platform

Watch the Webinar Highlights

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