Datasheet Optimizing Validation though a Risk Based Approach

Advantages of CSA – Computer Software Assurance – Over Traditional CSV

by David Gwyn |
Nov 21, 2022 |

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. 

About the Author

Mr. Gwyn is a strategic, creative, and data-driven Business Development and Technology Specialist with extensive expertise in building key partnerships, implementing business strategies, and deploying solutions across the life science and emerging technology industries. In October 2021 he joined fme US as the Business Unit Director for Business Consulting. For the past 30 years, he has led teams in the delivery of content management, clinical, and quality solutions with a recent focus on end-to-end Regulatory Information Management (RIM). His practice has evolved in parallel to the Life Sciences industry, moving from custom-developed software solutions to packaged-based implementations, and the development of methodologies and best practices to guide practitioners in realizing the greatest return on investment. Mr. Gwyn is passionate about helping organizations evolve from traditional to digital businesses and increase their ability to act with speed and agility.