Tag Archive for Auditing

How Often Should You Conduct Internal Audits?

Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…

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Internal Quality Audits: What to Target

Q: With your experience as an FDA investigator and independent auditor, can you advise me on some specific things to look for when I’m conducting internal quality audits? A: First, make sure all your required Quality System procedures are defined,…

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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…

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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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