Computer Software Assurance (CSA) is a revised framework designed to help drug and device manufacturers get clarity to efficiently achieve Computer System Validation (CSV).
How would you rate your current level of understanding for CSA? Little to none? You’re aware of it, but until that draft guidance is published, you’re not taking action? Are you the one trying to convince your company to adopt this new methodology so you can stop wasting time on screenshots and start focusing your efforts on testing?
No matter how you rate your understanding, let’s focus on getting your company ready for this paradigm shift.
As the FDA refocuses from compliance to quality, they encourage the use of automation and new technologies. USDM Life Sciences has been implementing a CSA methodology for our customers for more than two years. Here we offer guidance on how to make it work for you.
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Considering CSA? Here’s what you need to know
Update from the FDA on CSV Changes
How to Align Your CSV Program with the FDA’s CSA Approach
Q&A with the FDA on CSV Changes
CSA Approach Significantly Improves Platform Efficiencies
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