Tag Archive for Part 11

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…


FDA’s Expectations for Software Traceability

Q: It’s my understanding that FDA standards and guidelines call for software traceability of the requirements down to the level of the code (modules and functions). However, I believe a lot of companies may not be able to demonstrate requirements traceability down to…


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…