Legal & compliance · Skill
FDA QSR Forcing Questions
Use before an FDA inspection, QMSR internal audit or Form 483 response.
Open in PhởWhat the skill covers
The sections of its instructions, in order.
- 01 When to Run
- 02 The Six QSR Questions
- 1. Show me the complaint files from the last quarter — and the corresponding MDR reports.
- 2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
- 3. Show me the DHRs for products commercially distributed in last 2 years.
- 4. Show me CAPAs from the last 6 months with effectiveness verification.
- 5. Show me labeling (21 CFR 801) review for the most recent product launch.
- 6. If a Form 483 was issued in the last 3 years, show me the closure status.
- 03 Workflow
- 04 Output Format
- 05 Routing
- 06 Related
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Frequently asked questions
What does FDA QSR Forcing Questions do?
Use before an FDA inspection, QMSR internal audit or Form 483 response.
Is FDA QSR Forcing Questions free to use?
Yes. FDA QSR Forcing Questions is published by Alireza Rezvani under the MIT licence, and you can use it with a free Phở account.
How do I use FDA QSR Forcing Questions in Phở?
Press Open in Phở, then Try to apply it to your next message, or add the Regulatory & compliance audits set so Phở loads it whenever a request matches.
Does FDA QSR Forcing Questions need other tools?
No. It works in a normal Phở chat with what you type or upload.
Copied unchanged from alirezarezvani/claude-skills at commit c85b17e and credited to Alireza Rezvani, who is not affiliated with Phở. The full instructions and licence text ship with the skill inside Phở.