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FDA Audit

Postby orrkwankit » June 13th, 2016, 11:10 am

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I'm not sure if this is the best place to post this topic (Admin please move if required).

For those of us in the medical device industry how do you guys deal with FDA Audits? how do you organize DHF and controlled documents? I'm not sure if or how thumbnail sketches and concept sketches should be documented (and rev'd) as part of DHF in PDF form, scanned, or in docket.

What do you guys do?

Re: FDA Audit

Postby iab » June 13th, 2016, 4:39 pm


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For us, concept sketches are not a part of the DHF. We only use drawings and specs for the launch product, not all of the ideas we had before the launch idea. While out QA/RA group would like us to document those previous (and therefore "bad" ideas), it would slow the process to a crawl. We would have a launch every decade instead of 1-3 times a year.

I do agree with the QA/RA position that those "bad" ideas are the reason why the launch product is the launch product. A drawing, written spec and even the risk analysis can fall short on why a particular spec is a particular spec.

That said, when we do generate the DHF, we use the most ironically-named software, Agile. Organizes DCOs, ECOs, by product. We convert drawings to pdf files so the non-CAD users can view them. Formulations are Word files. The DHF (with design inputs, outputs, etc.), risk analysis, stability data will be Excel files.


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