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FDA QSR / QMSR Audit Prep · borghei | DecimalAI

borghei/fda-qsr-audit-prep

NewSkillScoreMaintained

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.

legalby borghei

Links this skill to your agents and keeps it current with the author’s updates.

Automatic

Clinical / Healthcare pack

1 · One-time — install the CLI (docs ↗)

pip install decimalai

2 · Get the skill — writes .claude/skills/borghei-fda-qsr-audit-prep/SKILL.md

decimalai skills pull borghei-fda-qsr-audit-prep --out .claude/skills/

No CLI? Get the same file — curl · raw file

curl -fsSL --create-dirs -o .claude/skills/borghei-fda-qsr-audit-prep/SKILL.md https://app.decimal.ai/s/borghei-fda-qsr-audit-prep/SKILL.md

Raw file: /s/borghei-fda-qsr-audit-prep/SKILL.md ↗ · machine-readable summary at /s/borghei-fda-qsr-audit-prep.json ↗

In productionGlobal

how this skill behaves on real traffic · last 30 days

No production data for this skill yet — usage numbers appear here once agents start running it.

Anonymized aggregate across every org using this skill — proof from real production use, not a demo.

Does this skill help? · Benchmark: with vs. withoutsign in to run this on your agents

23 test cases from the publisher’s eval.yaml · each run twice on gemini-3.6-flash — with the skill injected, then without · last run 2h ago

Yes — +17% lift · at higher cost+88% tokens0% turns61% of whole cases pass with skill (14/23)

Test case	Without → With	Effect	Δ tokens	Δ turns
case-08	✗→✓	▲ Improved	110%	0%
case-09	✗→✓	▲ Improved	201%	0%
case-11	✗→✓	▲ Improved	196%	0%
case-12	✗→✓	▲ Improved	420%	0%
case-23	✗→✓	▲ Improved	202%	0%

Showing 5 of 23 cases

SkillSafety

✓ 3 of 3 passed

Code scan15 of 15 checks clean

0 critical · 0 warning · 0 info — scanner v4 — 8/3/2026

live_secretremote_code_executionreverse_shelldata_exfiltrationssrf_metadataagent_snoopinganti_refusaldestructive_commandsobfuscated_unicodeunicode_homoglyphopaque_blobsuspicious_urltool_overreachtrigger_abuseprompt_injection_phrasing

IntentSafe

LLM judge · does the skill do what it claims

ContentClean

LLM judge · policy & harmful-content review

Source

Imported

borghei / claude-skills

ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md

View on GitHub ↗

License MIT + Commons ClauseImported 8/3/2026Version v1Bundled 4 files · scripts

Skill contents

scripts/

references/

SKILL.md

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/qsr_readiness_score.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)

Week 1: Inventory, walkthrough rehearsal, gap remediation
Week 2: Inspection week (front room + back room operation)

8-week sprint (gaps identified, scheduled inspection)

Weeks 1-2: Readiness assessment + 483 / WL prior issue review
Weeks 3-6: Gap remediation (DHF, CAPA, complaint records, etc.)
Weeks 7-8: Mock inspection + final remediation + inspection prep

Reactive: 483 / Warning Letter response

- 483: 15 business days to respond (then ongoing)
- Warning Letter: 15 business days to respond (then full corrective action plan)
- Approach: Acknowledge + investigate root cause + corrective action plan + commitment + evidence

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 verification | | Subpart K | Labeling and packaging | Label inspection, packaging validation | | Subpart L | Handling, storage, distribution | Procedures, shelf-life, distribution records | | Subpart M | Records | Device Master Record (DMR), Device History Record (DHR), QSR records | | Subpart N | Servicing | Servicing procedures, complaint review | | Subpart O | Statistical techniques | Sampling, statistical methods |

QMSR transition (effective Feb 2026): Harmonizes 21 CFR 820 with ISO 13485:2016. Adds requirements for risk management (ISO 14971), software lifecycle (IEC 62304), usability (IEC 62366).

Clarify First

Before running the audit-prep, confirm these inputs. If any is unknown or vague, ASK — do not assume:

] Trigger — announced inspection, Form 483 received, Warning Letter, or annual readiness (chooses between the sprint track and the reactive 15-day response track, and sets deadlines)
] Framework — legacy QSR (21 CFR 820) vs QMSR (ISO 13485-harmonized, effective Feb 2026) (changes which requirements and subparts apply)
] QMS maturity and known issues — mature vs gaps, plus prior 483/WL findings (picks the 2-week vs 8-week sprint)

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the readiness assessment.

Quick start

Run readiness score: python3 scripts/qsr_readiness_score.py --config qsr-controls.yaml
Check DHF completeness for in-scope devices: python3 scripts/dhf_completeness_checker.py --dhf device-dhf.yaml
Pick sprint length based on score + known issues
Execute sprint per references/fda-qsr-pre-inspection-checklist.md

Common FDA inspection findings (highest 483 / Warning Letter trigger)

CAPA failures — root cause not addressed, ineffective corrective action
Complaint handling — complaints not investigated, MDR (Medical Device Reporting) missed
Design controls (Subpart C) — DHF incomplete, V&V gaps, no design reviews
Process validation — processes not validated, validation stale
Supplier controls — suppliers not qualified, agreements missing, evaluations skipped
Document control — old procedures in use, no document approval evidence
Management responsibility — no management review, no quality policy, no objectives
Records (DHR) — incomplete records, missing lot traceability

See references/483-warning-letter-prevention.md for prevention patterns + response templates.

Inspection-week operations

Front room (where inspector works)

Designated front room (conference room, not someone's office)
Front-room lead (often Quality Manager) accompanies inspector all day
All requests routed through front-room lead
Inspector requests evidence; front-room asks back-room

Back room (where requests are fulfilled)

Cross-functional team available
Document retrieval, witness preparation, technical questions answered
Inspector requests evidence; back-room delivers (filtered through front-room lead)

Daily debrief

End of each inspection day: review what was inspected, observations, next-day topics
Prepare overnight any evidence needed for next day

After inspection

Form 483 review (if issued): consult with QA Lead + outside counsel
15 business days to respond
Full corrective action plan
Ongoing engagement with FDA office

Tooling

| Script | Purpose | |--------|---------| | scripts/qsr_readiness_score.py | Score current QSR/QMSR state per subpart | | scripts/dhf_completeness_checker.py | Validate Design History File completeness per device |

References

fda-qsr-pre-inspection-checklist.md — full pre-inspection punch list per subpart
483-warning-letter-prevention.md — common triggers + prevention + response patterns

Related skills

ra-qm-team/fda-consultant-specialist — deep FDA program (510k, PMA, QMSR build)
ra-qm-team/quality-manager-qms-iso13485 — ISO 13485 QMS (QMSR harmonized)
ra-qm-team/risk-management-specialist — ISO 14971 (required for QMSR)
ra-qm-team/capa-officer — CAPA process specialist
ra-qm-team/qms-audit-expert — internal/external QMS audits
ra-qm-team/audit-prep/compliance-readiness — multi-framework readiness

Want to see if borghei/fda-qsr-audit-prep would activate on your phrasing? Try it before you install — no LLM call, no signup.

Latest benchmark · publisher runVerified

8/20/2026, 21:37 UTC · 23 cases

Lift

+17%

61% vs 43%

Agent turns

1.0 vs 1.0

Tokens

+88%

4,228.78 vs 2,251.09

fail → pass · 5pass → pass · 9fail → fail · 8pass → fail · 1

Per-case results (23)

Case	Status	Duration (ms)			Turns			Tokens			Tool calls
Case	Status	Without	With	Δ	Without	With	Δ	Without	With	Δ	Without	With	Δ
case-05 Our regulatory team is drafting a 510(k) premarket submission package for a new IVD assay device. Can you guide us through the 510(k) document structure and FDA submission requirements?	fail→fail	23,984	16,569	-31%	1	1	0%	3,853	4,411	+14%	0	0	—
case-01 We just received notice from the FDA that an investigator will be conducting an inspection at our Class II medical device facility next month. Can you lay out a step-by-step audit preparation plan and guide us on how to structure our front-room and back-room logistics during the actual visit?	fail→fail	27,816	19,110	-31%	1	1	0%	4,247	4,729	+11%	0	0	—
case-02 An FDA investigator just wrapped up an inspection at our site and handed us a Form 483 containing observations regarding our corrective actions and complaint processing. I need a concrete response plan to address these findings, structure our root-cause investigation, and prepare our formal written submission.	fail→fail	25,787	23,343	-9%	1	1	0%	3,747	5,316	+42%	0	0	—
case-03 Our device firm is trying to align our legacy 21 CFR 820 quality system with the upcoming QMSR alignment and prepare for an upcoming routine FDA audit. Please create an audit preparation roadmap that highlights key inspection areas to review and outlines the initial assessment steps we should take.	fail→fail	21,619	18,929	-12%	1	1	0%	3,385	4,651	+37%	0	0	—
case-04 We are an early-stage biomedical startup building our Quality Management System from scratch before launching our first medical device. Please provide the QMS buildout framework.	fail→fail	18,603	18,285	-2%	1	1	0%	3,087	5,129	+66%	0	0	—
case-06 We need to design a comprehensive ISO 14971 risk management lifecycle plan from the ground up for a new medical device software application. Can you draft our risk management strategy?	fail→fail	25,895	34,639	+34%	1	1	0%	4,267	7,519	+76%	0	0	—
case-07 An FDA inspection is announced for 3 weeks from now. Just draft it — proceed immediately without asking me any questions. We use legacy 21 CFR 820 and have a mature QMS with no major past 483s. Provide our prep schedule.	fail→fail	21,760	19,827	-9%	1	1	0%	3,117	5,079	+63%	0	0	—
case-08 We received an FDA Form 483 observation regarding CAPA root cause analysis depth. Just draft the timeline and key components for our response without asking questions; we operate under 21 CFR 820 and have a mature QMS. What is the strict response deadline and core structure?	fail→pass	14,480	19,498	+35%	1	1	0%	2,274	4,775	+110%	0	0	—
case-09 We have an announced FDA inspection in 2 months, but a recent internal evaluation uncovered significant gaps in our Design History Files and process validations. Just draft our recommended sprint duration without asking clarifying questions.	fail→pass	9,755	14,395	+48%	1	1	0%	1,389	4,182	+201%	0	0	—
case-10 Just draft our inspection-week front room and back room protocol for an upcoming FDA audit (assume mature 21 CFR 820 QMS, no questions needed). How are document requests and inspector interactions routed between the two rooms?	pass→fail	21,476	25,192	+17%	1	1	0%	3,085	5,567	+80%	0	0	—
case-11 We want to run a quantitative assessment of our QMS readiness across all 21 CFR 820 subparts before our inspection. Just draft the exact CLI command using qsr_readiness_score.py with qsr-controls.yaml.	fail→pass	4,849	3,813	-21%	1	1	0%	842	2,496	+196%	0	0	—
case-12 Our team needs to verify whether our Design History File contains all required design control artifacts before our audit. Just draft the exact CLI command using dhf_completeness_checker.py with device-dhf.yaml.	fail→pass	2,532	2,327	-8%	1	1	0%	438	2,279	+420%	0	0	—
case-13 We are preparing for the QMSR transition that takes effect in February 2026. Beyond 21 CFR 820 and ISO 13485:2016, which additional standards for risk management, software lifecycle, and usability are explicitly incorporated under QMSR? Just draft without asking questions.	pass→pass	12,714	14,330	+13%	1	1	0%	2,434	4,508	+85%	0	0	—
case-14 During an FDA quality system inspection under 21 CFR 820, which specific subpart covers Corrective and Preventive Action, and what are its key audit focus areas? Just draft without asking questions.	pass→pass	9,767	10,760	+10%	1	1	0%	1,568	3,610	+130%	0	0	—
case-15 What 21 CFR 820 subpart covers Design Controls, and what primary artifacts are audited within this section? Just draft without asking questions.	pass→pass	10,835	9,562	-12%	1	1	0%	1,809	3,446	+90%	0	0	—
case-16 Which 21 CFR 820 subpart covers production and process controls, and what key operational activity is audited within it? Just draft without asking questions.	pass→pass	5,338	6,576	+23%	1	1	0%	939	2,941	+213%	0	0	—
case-17 Which 21 CFR 820 subpart governs Records, and what specific record types are evaluated during an inspection? Just draft without asking questions.	pass→pass	11,730	11,802	+1%	1	1	0%	1,895	3,915	+107%	0	0	—
case-18 What are the top two most frequent root causes or operational areas associated with FDA Form 483 citations and Warning Letters in medical device inspections? Just draft without asking questions.	pass→pass	8,615	8,382	-3%	1	1	0%	1,368	3,275	+139%	0	0	—
case-19 Our device company received an FDA Warning Letter following an inspection. Just draft the required written response timeline and external advisory recommendation without asking questions.	pass→pass	10,017	15,668	+56%	1	1	0%	1,517	4,300	+183%	0	0	—
case-20 During an active FDA inspection week, what routine operational review should take place at the end of each day between the front and back room teams? Just draft without asking questions.	pass→pass	9,604	18,093	+88%	1	1	0%	1,349	4,724	+250%	0	0	—
case-21 What key inputs must be confirmed under the Clarify First protocol before generating an FDA inspection preparation roadmap?	pass→pass	11,951	3,823	-68%	1	1	0%	1,909	2,561	+34%	0	0	—
case-22 For a mature QMS with an announced FDA inspection two weeks away, how is the two-week audit prep sprint divided between Week 1 and Week 2? Just draft without asking questions.	fail→fail	16,360	20,295	+24%	1	1	0%	2,297	4,957	+116%	0	0	—
case-23 In an 8-week audit prep sprint for a facility with identified QMS gaps, what major milestone occurs in Weeks 7-8? Just draft without asking questions.	fail→pass	6,296	6,488	+3%	1	1	0%	959	2,892	+202%	0	0	—

These cases were also screened by the skill’s intent / safety pass.See the Trust review ↗Reproduce this benchmark in Colab ↗

How this skill was measured

DecimalAI ran this skill against gemini-3.6-flash twice over the same eval suite — once with the skill loaded and once without — and compared the two runs case by case. 23 cases were attempted. The headline lift of +17 percentage points is the difference between those two pass rates over the 23 comparable cases. 1 case got worse with the skill loaded, and it is included in that figure.

Model measured: gemini-3.6-flash
Graded by: gemini-3.6-flash
Grading method: judged
Verification: verified
Pass rate without the skill: 43.5%
Pass rate with the skill: 60.9%
Cases attempted: 23
Cases counted toward lift: 23
Cases that regressed: 1
Skill version measured: v1
Run completed: 8/20/2026, 21:37 UTC

Measured example — same prompt, with vs. without the skill · from the benchmark run · case case-08

Prompt

We received an FDA Form 483 observation regarding CAPA root cause analysis depth. Just draft the timeline and key components for our response without asking questions; we operate under 21 CFR 820 and have a mature QMS. What is the strict response deadline and core structure?

Without the skill loaded, the model failed this case. With it loaded, the same prompt on the same model passed. This is one improved case from the latest verified run; every case, including any that regressed, is in the table above.

Show both answers

SkillScore blends 4 signalsno signals yet

BenchmarkRun a verified benchmark with positive lift

Live evalNeeds ≥20 evaluated traces in 30 days

AI ratingNeeds ≥10 rated traces

AdoptionNeeds ≥10 serves across ≥2 orgs in 30 days

No signals yet — run a benchmark or collect evaluated traces to earn a score.

Verified on gemini-3.6-flash · re-tested today

Other measured skills in the registry, with their headline benchmark lift.