Tag Archive for Internal Audit

Supplier Audits: Are There Any Alternatives?

Q: We’ve run into an obstacle with our supplier audits. How would you handle suppliers who won’t let you audit their facilities because either you’re not a big enough customer or they say they don’t have the time?A:  First of all, remember…

Share

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