Optimizing Validation through a Risk-Based Approach:
Leveraging Computer Software Assurance (CSA)


About this Datasheet

Tired of the mountains of paperwork produced to validate a new or updated system? Frustrated with your company’s inability to upgrade existing systems because of the burden of validation? Then let fme help you shift from the traditional computer system validation (CSV) approach to a more streamlined and efficient risk-based method embodied in computer software assurance (CSA).

Little has changed in processes around validation over the past twenty years. By understanding how CSA can be applied in your company, you will leave a large portion of the paperwork traditionally created behind and focus on the important aspects of your software-supported business processes. Learning to optimize your validation activities by focusing on the processes that impact patient health and safety increases your agility to test and adopt new business processes and systems. Read on to learn about fme’s methodology, templates and services that accelerate your validation activities and help you stay competitive in the life sciences industry

Target Group

  • Regulatory Information Managers
  • Quality and Manufacturing Managers
  • IT Managers


  • Life Sciences


  • Minimized compliance risk – Avoid scrutiny by aligning
    your validation approach with health authority guidelines
  • Decreased validation costs – Reduce documentation
    and focus on risk areas
  • Reduced validation time – Accelerate computerized
    system upgrades through a streamlined CSA approach


fme is always looking for top talent to join our team. Review the listings above to learn the details of our current openings.

If you have any questions regarding the application process please contact me. I’m looking forward to your request.

David Gwyn
Business Unit Director – Business Consulting