AI for regulated workdrafts, not decisions.
Three specific, high-value workflows: trend-summarise deviations / NCRs / complaints to surface CAPA leads, generate competency exams from an SOP with SOP-anchored rationales, and translate technical documents while keeping regulated terms verbatim. Every output is a draft. A qualified human reviews and e-signs before it touches a record.
What changes once V5 AI is live.
Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.
What changes the day you switch this on.
- Manual, paper-driven, and only audited after the fact.
- Tribal knowledge in spreadsheets and shared drives.
- Errors caught at month-end — too late to fix the batch.
- Different teams keep their own version of the truth.
- Deviation trend summariser
- Exam-from-SOP
- Regulated translation
- Human-in-the-loop by default
What you actually get
Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.
Deviation trend summariser
Reads raw deviation / NCR / complaint text and surfaces recurring themes, emerging risks and suggested CAPA leads.
Exam-from-SOP
Generates 3–15 multiple-choice questions from an SOP with rationales and specific clause anchors so a trainer can publish in minutes, not days.
Regulated translation
Translates SOPs and work instructions while keeping regulated terms (Lot, eDHR, BMR, CoA) verbatim across languages.
Human-in-the-loop by default
Every output is marked draft. A qualified reviewer e-signs before anything is committed to a record — Part 11 stays intact.
One operator action — a complete, signed record.
What it leaves behind
- No customer data used for model training
- Outputs always draft + reviewer e-sig
- Industry-aware terminology preserved
The clauses this satisfies
What buyers ask before they switch on AI for regulated work.
Keep exploring
MES
Operator-led execution: scan-gated dispense, step-by-step kiosk, equipment + scale integration, live yield. Built for regulated process & discrete manufacturing.
WMS
Receiving, putaway, transfers, cycle counts, picks, pack & ship — all lot-aware, bin-accurate, FEFO/FIFO-enforced and barcode-driven.
QMS
Built-in QMS: deviations, CAPA, supplier scorecards, in-process AQL, release-by-exception. Aligned with 21 CFR 211/820, ISO 13485 and 111.
Got questions, or want to see it on your shop floor?
Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.