V5 Ultimate
Module · Periodic document review

Periodic document reviewevery SOP gets re-read, every cycle.

Per-document review cadence with named owner and email/Slack reminders. The review screen presents diff vs last version, training-acknowledgement coverage and any CAPAs that touched the document. Past due? V5 surfaces it on the QA dashboard and (optionally) blocks the kiosk operations governed by it until reviewed.

Start free — no card
Signals from the floor

What changes once Periodic document 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.

Time to first batch
90 days
validated, e-signed, live
Audit-ready records
0%
Part 11, immutable, queryable
Operator adoption
0%
kiosk-first, no training-week
Manual paperwork
100
eliminated at the step
Before / after

What changes the day you switch this on.

Before V5
  • 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.

  • Soft warnings operators can dismiss — and do.

With V5
  • Cadence per document

  • Diff + impact in one pane

  • Two-sig review e-sig

  • Optional hard block

What you actually get

Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.

Cadence per document

Annual, biennial, every 3 years — set per category or per document.

Diff + impact in one pane

Reviewer sees changes since last review, who has acknowledged the current version, and which CAPAs touched it.

Two-sig review e-sig

Author + independent reviewer, captured with meaning per 21 CFR 11.50.

Optional hard block

For critical SOPs, past-due review can lock the related kiosk operation until a reviewer signs.

V5

Curious how this lands in your environment?

AI inside Periodic document review

Where AI actually earns its place.

AI prepares the reviewer's pane before they sit down — surfacing exactly what changed and what's still open — so the periodic review is a real re-read, not a rubber stamp.

  1. 01

    Change-impact summary for the reviewer

    AI reads the diff since the last version and writes a short summary of what actually changed — a tolerance, a step order, a signature point — instead of leaving the reviewer to spot it in redlines.

  2. 02

    Acknowledgement and CAPA cross-check

    Before the review, AI checks training-acknowledgement coverage for the current version and flags any linked CAPA that touched the document since the last cycle, putting both in front of the reviewer in one pane.

  3. 03

    Overdue-review triage

    On the QA dashboard, AI ranks past-due documents by whether they gate a kiosk operation, so the SOP that would block production gets a reviewer's attention before a lower-risk work instruction.

What AI never does

AI never approves a document review and never removes a kiosk hard-block — the two-signature review, author plus independent reviewer, is the only thing that closes the cycle.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • Per-document cadence
  • Diff + ack coverage + linked CAPAs
  • Two-person e-sig
  • Optional kiosk hard-block
Regulatory anchor

The clauses this satisfies

21 CFR 820.40 (document controls)21 CFR 211.100 (written procedures)ISO 13485 §4.2.3EU GMP Annex 11 §4
Engineered on
21 CFR Part 11 e-signatures
Immutable audit trail
Multi-tenant RLS isolation
GS1-128 license plates
Two-way ERP adapters
Common questions

What buyers ask before they switch on Periodic document review.

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.