Management Reviewassembles itself from the data you already have.
21 CFR 820.20(c) and ISO 13485 §5.6 both require periodic, documented Management Review. Most teams run it in PowerPoint, with slides screenshot from another system, and lose the action items in someone's inbox. V5's Management Review pulls live KPIs (CAPA aging, audit findings, complaints, deviation trends, supplier performance, training compliance), captures attendance and minutes, tracks action items with owners and due dates, and seals the whole thing as a signed PDF you hand to the auditor.
What changes once Management Review 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.
- Variances and overcharges discovered at month-end COGS.
- 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.
- Live KPI roll-up
- Standard agenda template, customisable
- Attendance, minutes, action items
- Signed PDF, versioned
What you actually get
Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.
Live KPI roll-up
CAPA aging buckets, open audit findings, complaint trends, deviation rate per WO, supplier performance scorecards, training compliance — pulled live, not pasted from a screenshot.
Standard agenda template, customisable
Pre-built agendas for ISO 13485 §5.6.2 and 820.20(c) inputs — review of audits, customer feedback, process performance, product conformity, status of CAPAs, follow-up from prior meeting, regulatory changes.
Attendance, minutes, action items
Capture attendees, decisions, and action items with owner + due date. Actions auto-roll into the owner's dashboard until closed.
Signed PDF, versioned
Lock the meeting; V5 generates a Part 11-signed PDF stored against the year. The next quarter's review opens with prior-meeting follow-up already on the agenda.
One operator action — a complete, signed record.
What it leaves behind
- KPIs pulled live from CAPAs, audits, complaints, training
- Action items roll into owner dashboards
- Signed PDF stored against the calendar year
- Prior-meeting follow-up auto-seeded into the next agenda
The clauses this satisfies
What buyers ask before they switch on Management Review.
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.