AI CAPA · Deviation · 5-Why · Fishbone
AI drafts for CAPA and deviation investigations, approved by people.
Start from a draft built from the linked evidence; investigators edit it and sign the conclusions.
A Draft, Not a Decision
AI drafts narratives and candidate root causes from linked evidence.
Investigators Edit
Every draft is reviewed and changed by a person.
Signed by People
Conclusions and actions are approved with e-signatures.
What goes wrong today3 common problems
First Drafts Eat the Investigator's Day
80% of investigator time is spent typing narrative, not investigating.
Root-cause tools are underused
5-Why and fishbone become box-ticking because filling them from a blank template is slow.
Effectiveness plans are boilerplate
Verification steps get copy-pasted across CAPAs, weakening the effectiveness gate.
Everything V5 does here5 capabilities
Draft from Evidence, Not from Scratch
V5 pulls the deviation, associated batch data, prior similar cases and the operator interview transcript into a first-pass narrative — with confidence and citations.
Candidate Root Causes Ranked
5-Why chains and fishbone branches proposed against precedent — investigator confirms, edits or rejects with reason.
Precedent-Aware Action Plans
Similar closed CAPAs surface as reference so the plan builds on what worked, not what was fastest to write.
Verification Tailored to the Action
Effectiveness plan proposed per action type (SOP change, retraining, equipment fix) — not a generic checkbox.
Nothing Auto-Closes
Human approval, e-signature and effectiveness verification all remain human-in-the-loop. AI drafts; people decide.
How it works, step by step4 steps
AI drafting rolls out in three stages so QA governance keeps pace.
- Read-only summarisation. AI summarises the deviation for the investigator — no drafting yet.
- Assist Mode. AI drafts on-demand at investigator request.
- Full Drafting. Every new CAPA opens with a drafted first pass; investigator challenges and approves.
- QA Sampling. QA samples AI-drafted CAPAs for quality-of-reasoning review.
What to look for when choosing
AI drafting is a productivity feature — but only if effectiveness stays human-owned. Criteria that keep both true.
Evidence-Anchored Drafts
Are drafts built from the actual source records, not from generic templates? Drafts anchored to the deviation, batch, prior CAPAs and interview transcript.
Ranked Candidate Root Causes
Are candidate causes ranked with rationale, or one prose paragraph? 5-Why and fishbone with per-branch citations.
Action-Typed Effectiveness Proposal
Is the effectiveness plan tailored to the action type? Per-action-type verification proposal.
Human-in-the-Loop Enforced
Is closure structurally blocked without human sign-off? Approval, signature and closure all human.
Precedent Surfaced
Are similar closed CAPAs surfaced during drafting? Precedent surfaced with outcome data.
Audit Trail on Every AI Edit
Is every AI-drafted claim traceable to its source and to reviewer attestation? Full trail from source → draft → reviewer approval.
V5 Compared with Other Approaches
AI-assisted CAPA drafting vs pure-human drafting vs generic AI writing tools.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Evidence anchoring | N/A | N/A | Native |
| Ranked causes | Manual | Free-form | Ranked with rationale |
| Precedent surfaced | Memory | Rare | Automatic |
| Verification tailored | Boilerplate | Often generic | Per action type |
| Closure human | Yes | Yes | Yes (structurally enforced) |
Regulations this supportsYour quality team stays responsible for compliance
The CAPA clauses that AI drafting must respect.
21 CFR 820.100(a)
AI drafts within the SOP-defined CAPA lifecycle — it does not create a parallel path.
21 CFR 820.100(a)(3)
AI proposes; investigator confirms; effectiveness proves.
ICH Q10 §3.2.2
CAPA remains the record; AI accelerates authorship.
21 CFR Part 11 §11.10(k)
Ask the V5 team which AI details are documented for the assists you enable; validation remains your responsibility.
Standards Referenced
- 21 CFR 820.100 (CAPA — medical devices)
- 21 CFR 211.192 (production record review)
- ICH Q10 §3.2.2 (CAPA system)
- ISO 13485 §8.5.2 (corrective action)
- EU GMP Chapter 1 §1.4(xiv) (CAPA)
Common questions3 answers
- Does the AI ever close a CAPA?
- No. Draft is AI; approval, signature and effectiveness verification are always human.
- How do I audit an AI-drafted narrative?
- Every drafted claim carries the record it came from and the reviewer's attestation of accuracy at approval time — auditable end-to-end.
- Can it be turned off?
- Per-tenant and per-user. Sites in the middle of validation typically turn it on read-only first, then on-draft, then on-suggest — one gate at a time.