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 itContinue Reading
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)Continue Reading
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As the FDA New, draft guidance on Computer Software Assurance (CSA) Guidance gains traction, more and more organizations are recognizing the value of a leaner approach and for those that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.Continue Reading
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