Agent skill · marketing growth · borghei
fda-qsr-audit-prep
FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.
Why this skill is useful
Provides specific procedural guidance and templates for FDA audit preparation that the AI wouldn't reliably generate on its own.
What it needs
About 4k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
FDA QSR / QMSR Audit Prep Operational playbook for FDA inspection preparation under Quality System Regulation (21 CFR 820) and the transitioning Quality Management System Regulation (QMSR, fully effective 2026, harmonizing with ISO 13485:2016). When to use this skill vs. fda-consultant-specialist: This skill: FDA inspection imminent OR 483/Warning Letter received; need sprint fda-consultant-specialist: building / maintaining QMS; multi-quarter --- When to use this skill Situation Skill applies ----------- --------------- FDA inspection announced (or unannounced visit imminent) Yes — start immediately Form 483 observation received Yes — scripts/qsrreadinessscore.py to assess + plan response Warning Letter received Yes — plus engage outside FDA counsel Annual readiness assessment Yes — periodic sprint Building QMS from scratch Use ra-qm-team/fda-consultant-specialist Medical device submission (510k / PMA) Use ra-qm-team/fda-consultant-specialist --- The audit-prep sprint at a glance 2-week sprint (announced inspection, mature QMS) 8-week sprint (gaps identified, scheduled inspection) Reactive: 483 / Warning Letter response --- QSR / QMSR key audit areas 21 CFR 820 Subpart Topic Audit focus -------------------- ------- ------------- Subpart B Quality system Management responsibility, quality policy, planning Subpart C Design controls Design history file (DHF), design reviews, V&V Subpart D Document controls Document approval, change control, distribution Subpart E Purchasing controls Supplier qualification, agreements, evaluations Subpart F Identification and traceability Product ID, lot/batch traceability Subpart G Production and process controls Process validation, environmental controls, equipment maintenance Subpart H Acceptance activities Receiving, in-process, finished device acceptance Subpart I Nonconforming product Identification, segregation, disposition Subpart J Corrective and preventive action (CAPA) CAPA process, root cause analysis, effectiveness verific …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/fda-qsr-audit-prep