Checklist

Management Reviews: A Checklist for Compliance

An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…

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Checklist for Complaint Handling Procedures

Proper management and follow-up of product complaints is one of the major stumbling blocks for FDA-regulated companies. Compare your existing Complaint Handling Procedures against this checklist of best practices: √ Define your complaint sources √ Decide how a complaint is…

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Part 11 Cheat-Sheet: What Does Part 11 Really Cover?

In proportion to their relatively short length, 21 CFR Part 11 and FDA’s Part 11 Scope and Application guidance generate a huge amount of confusion and questions from EduQuest’s clients. So we’ve developed the following Part 11 cheat-sheet to help you better understand compliance. When in…

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