FDA Audit

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.