FDA-era compliance
Re-walk every clinical-trial and pharmacovigilance decision in front of an FDA reviewer.21 CFR Part 11 evidence. ALCOA+ retention. One hash-chained replay trail.
The FDA / GxP auditor’s questions almost never match the dashboard your model team built — so Plumbline writes every clinical-trial decisioning, pharmacovigilance signal review, and SaMD post-market record the model rendered onto an HMAC-SHA-256 chain that’s already the answer. Per-workspace 21 CFR Part 11 evidence package, ALCOA+ retention addendum, GMLP-attested validator, and a tamper-evident audit PDF your FDA reviewer can re-derive from the public /verify page.
§01 · Auditor posture
What 21 CFR Part 11, ALCOA+, and GMLP ask for — and where Plumbline lives in the answer.
The FDA / GxP auditor’s questions are almost always the same. Every row below is a real regulator expectation and the Plumbline artifact the ledger already produces on the way through — no after-the-fact paste-up.
- 21 CFR Part 11 · §11.10(a)–(k)
Electronic records and signatures live in a validated closed system; the audit trail captures every create / modify / delete against the same record.
Plumbline artifact · PART 11 · CLOSED-SYSTEMPer-workspace HMAC-SHA-256 chain binds input digest, scorer output, model id + version, and timestamps on every record. Tamper-evident audit PDF is co-signed onto the same chain.
- 21 CFR Part 11 · §11.50 / 70
Electronic signatures are permanently linked to the record they sign, and the signatory identity is independently re-derivable from the row.
Plumbline artifact · SIGNATURE · LINKEDPer-workspace signing key anchored to the buyer’s KMS. Signer identity + key fingerprint ride on the same canonical-JSON row as the decision; the signature is provable from the record alone.
- ALCOA+ · data integrity
Records are Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available throughout their retention window.
Plumbline artifact · ALCOA+ · CHAINEDChain at write time (contemporaneous). Canonical-JSON view (legible / accurate). Key-anchored HMAC (attributable / enduring). Tombstoned deletion record (consistent / available). One bundle, not four.
- ICH E6(R3) · GMLP
Computerised systems supporting trial decision-making are validated, with an audit trail of changes and role-based access controls governing who can change a model artifact.
Plumbline artifact · GMLP · VALIDATEDModel card + independent validator + rationale evaluator all ride one chain. Access-scope tuples set at write time; change-control events are signed records, not wiki edits.
- FDA AI/ML SaMD · 21 CFR 820.198 / PCCP
AI/ML medical-device software has a written change-control plan and post-market surveillance tied to drift monitoring across the model lifecycle.
Plumbline artifact · SaMD · PCCP-LINKEDDrift ledger + incident records ride the same chain. The cause → detect → resolve sequence is provable end to end against a signed audit-export — reviewers walk back the SaMD lifecycle, not a slide deck.
- FDA GMLP · CDS expectations
AI assisting risk evaluation of adverse-event signals records both the rationale behind the recommendation and the source it relied on.
Plumbline artifact · CDS · ATTRIBUTEDIndependent rationale evaluator + source-attribution column on the same row as the signal score. The pharmacovigilance reviewer reads the basis, not just the recommendation.
- EU AI Act · Annex IV technical documentation
Technical documentation is reproducible from on-chain records alone — provenance, version, and intended purpose can be re-derived without a vendor round-trip.
Plumbline artifact · ANNEX IV · RE-DERIVABLETamper-evident audit PDF is re-derivable from /verify. Sub-processor matrix + signature chain ride the same record. Verification is pure computation, no oracle or platform call back to engineering.
§02 · The replay walk-back
An AI-assisted AE triage, opened two quarters later.What the record carries — and what the FDA reviewer walks back.
- 1.What decision did the model surface?The PV triage path (expedite 15-day reporting) and the underlying MedDRA-mapped signal sit on the same row as the model version and the rationale evaluator’s score.
- 2.Was the basis for the expedited classification on the record? ALCOA+ requires contemporaneous capture with rationale and source. The evaluator set signs both, pins them to the row, and includes the MedDRA SMQ citation on the chain itself.
- 3.Did the calibration drift before or after? Score distribution walks back through the same ledger 30, 60, or 90 days at a time — no separate PCCP monitoring lake to reconcile against the production record.
- 4.Who has read this record since? Scope is set at write time. PV-OPS, the medical reviewer, and the audit role are stamped on the row against the FDA-scoped access list — no after-the-fact redaction.
- 5.Has the record been edited since capture? The HMAC-SHA-256 chain breaks visibly at the next record; tampering is detected at fetch, not at audit time.
- 6.What does the FDA reviewer hand back to counsel? A tamper-evident audit PDF (model card + record hash + signature chain), re-derivable from the public /verify page — counsel reads the same bundle, once.
§03 · Cross-links
Read next, by buyer intent.
Reserve a pharma pilot, or send the procurement team our Part 11 evidence packet.
Buying for a clinical-AI or pharmacovigilance program and want the walk-through? Drop your email and the Part 11 scoping checklist lands in your inbox before any contract is drawn up. Buying at the enterprise level with a validation plan already on the desk? Send the procurement team the intake form and we'll reply with the evidence packet and a short validation offer.
We'll never share your email. No marketing blast — only the next-step note when a slot opens. If you already have a Part 11 validation plan in flight, mention it on the call.
§06 · Pricing
Ready to see this on your models?
Start with the $1,000 Evidence Pilot: one workflow, one model, and 30 days ending in a replayable evidence package. Plumbline captures forward from the moment you connect, and the full pilot fee is credited toward Regulated Team.