Validation Modernization - An Agile approach to compliance with CSA

With the soon to be released FDA Computer Software Assurance (CSA) guidance, Computer Software Assurance for Manufacturing, Operations and Quality System Software, there is opportunity to optimize how organizations perform verification and validation of:

• medical device products,
• software development following an SDLC process,
• and validation of COTS systems.

What we have found is, it’s no longer just about people, process, and tools. An organization’s culture must change to take full advantage of the soon to be released FDA guidance.