Tag Archive for Data Integrity

Part 11 Password Safeguards: What’s Really Required?

Q: My question concerns the requirement for Part 11 password safeguards (Part 11.300(d)) that prevent unauthorized use of passwords or identification codes. We’ve always considered the “detect and report” portion of this requirement to include logging unsuccessful attempts and then reviewing those…

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Audit Trail Corruption: How to Correct and Document It

Q: We’re a laboratory software developer. Recently, while examining a customer’s data, we discovered some corruption in their audit trail data — a few duplicate records. We’re tracking down how this happened, and of course we will correct the root cause. However, my question…

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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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