Tag Archive for Electronic Signature

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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Best Practices for Part 11 Audit Trails

Do you understand FDA’s expectations for Part 11 audit trails? EduQuest’s staff experts have conducted literally thousands of site inspections around the globe. Here’s a quick self-check from our Compliance Toolkit to ensure you’re using the best practices for your audit trails. Are your…

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