Tag Archive for Audit Trail

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…

Share

FDA Requirements for Source Data

Q: I’m trying to locate the source of the regulatory requirements to 1) maintain original source data as part of the official record and 2) maintain each copy of an executed qualification/validation protocol. Can you point me in the right direction?…

Share

Is FDA OK with General or Shared Passwords?

Q: I’m reviewing our policy on shared passwords and accounts. We’ve issued a limited number of general passwords to supervisors or operators on the production floor so they can retrieve production documents electronically. Under 21 CFR Part 11.300(a), is it…

Share