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.
Curious how this lands in your environment?
Where AI actually earns its place.
AI turns the live KPI roll-up into the first draft of the meeting itself, so the quality team walks in with an agenda and a narrative instead of a blank slide deck.
- 01
KPI narrative drafted from the roll-up
AI writes a short summary of CAPA aging, audit findings, complaint trends, deviation rate and training compliance for the quarter — highlighting what moved since last review — so the meeting starts with a briefing, not a spreadsheet dump.
Cuts prep time for the quality manager from a day to an hour of review.
- 02
Prior-action follow-up chased automatically
AI checks the status of every action item from the last Management Review and flags anything still open, with the owner and how overdue it is, so nothing gets quietly dropped from the agenda.
- 03
Minutes drafted from the discussion
During the meeting, notes taken against each agenda item are turned into a structured minutes draft — decisions, owners, due dates — for the chair to correct and finalise before signing.
- 04
Trend flagging across quarters
AI compares this quarter's KPI set against the last four and calls out any metric moving the wrong way for two consecutive reviews, so a slow-building issue doesn't wait a year to surface.
AI never sets the agenda decisions, never closes an action item, and never signs the review — it drafts the KPI summary and minutes for the meeting chair and attendees to approve.
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.
The rest of the platform this plugs into.
V5 isn't a bolt-on. Every module shares the same data, the same audit trail, the same operator. Pick where to look next.
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.