Stephen J Cook - December 11th, 2020 Computer Software AssuranceISPE GAMP

CSA - Is Computer Software Assurance Cheating?

CSA is literally catching fire, but there remains a lot of bad information out there. Something I hear (or some variant of) every week is: "Is CSA cheating?" If CSA is a simplified, streamlined approach (test more and document less), how can it

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Stephen J Cook - October 5th, 2020 21 CFR Part 11

FDA 21 CFR Part 11 ERES Checklists? Do this instead!

21 CFR Part 11 Checklists. We've come a long way....or have we? The year is 1997. Bill Clinton is in his second term, Windows 95 is revolutionary, a laptop only weighs 6-8 pounds and 21 CFR Part 11, the US Food and Drug Administration's (FDA)

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Stephen J Cook - September 13th, 2020 Computer System Validation(CSV)

FDA's New Computer Software Assurance - Impacted SOPs

As the FDA New, draft guidance on Computer Software Assurance (CSA) Guidance gains traction, more and more organizations are recognizing the value of a leaner approach and for those that have already implemented CSA, they're realizing it.

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