Change control software where nothing reaches the floor without sign-off.
V5 routes every proposed change — SOP, recipe, equipment, supplier, software — through impact assessment, change control board review, validation, training reassignment and post-implementation review. The kiosk only sees the new version after every gate is e-signed.
What breaks without this.
Changes go live before training catches up
A new SOP is approved on Tuesday; the floor is still running the old one on Friday because no one closed the loop.
Impact assessment is a checkbox, not a process
Reviewers tick 'no impact' to move on, and the validation team finds out three months later.
Post-implementation review never happens
The change is 'done' the moment it's deployed — and nobody verifies it actually worked.
Records-by-execution. Compliance, by design.
Structured impact assessment
Quality, regulatory, validation, training, environmental and supplier impacts each captured by the right SME with an e-signature.
Change Control Board routing with e-quorum
Multi-disciplinary review with role-based signatures, parallel and serial routing, and automatic escalation on overdue.
Validation deliverables linked to the change
URS, FRS, IQ/OQ/PQ, traceability matrix — all attached to the change record, all gated before release.
Training reassignment fires on approval
The moment the SOP revision is approved, training is reassigned and the kiosk is locked until operators re-acknowledge.
Mandatory post-implementation review
V5 won't close the change without a scheduled PIR and signed evidence that the change achieved its stated objective.
Proof points
- Floor sees the new version only after every gate is e-signed
- Validation deliverables linked to the change record — no orphan IQ/OQ
- PIR mandatory before closure — auditors stop reopening 'closed' changes
- Full Part 11 audit trail on every signature
Built to satisfy
- ICH Q10 §3.2.3 (change management system)
- 21 CFR 211.100 (written procedures — production & process control)
- 21 CFR 820.70(b) (production & process changes — devices)
- ISO 13485 §7.3.9 (control of design and development changes)
- EU GMP Chapter 1 §1.4(xv) (change control)
Related on V5
Frequently asked questions
What is change control software?+
Change control software manages the lifecycle of any proposed change to a GMP-regulated system — SOP, recipe, equipment, supplier or software — from proposal through impact assessment, CCB review, validation, implementation and post-implementation review, with a Part 11 audit trail throughout.
Does V5 link change control to training?+
Yes. When a change updates an SOP, the affected training records reassign on approval and the kiosk locks the relevant steps until operators re-acknowledge.
Can V5 enforce a Change Control Board quorum?+
Yes — role-based e-signature rules, parallel and serial routing, escalation on overdue, and lockout if the quorum isn't met.
How fast can we deploy?+
Change control is part of the V5 Quality module — live in 7 days with standard onboarding, including migration of in-flight changes.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.