Step by Step approach to achieve an FDA/MDIC approved Quality Management System
As the quote goes, "Many hands make light work." (John Heywood, 1546) This is very true with a Quality Management System, but not so if your QMS is still on paper. While there need to be several controls put in place plus various sets of eyesContinue Reading
Why is an electronic Quality Management System (eQMS) important?
As humans, we are prone to making errors. Why? Our psychological, physical, expressive, and cerebral capabilities do not always function efficiently. To add to it, we are still making use of paper even in 2021 to record data manually, instead ofContinue Reading
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As the FDA New, draft guidance on Computer Software Assurance (CSA) Guidance gains traction, more and more organizations are recognizing the value of a leaner approach and for those that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
Copyright © 2021 Compliance Group All rights reserved.