Change control · CCB · MOC
Change control with impact assessment and signed approval.
Assess the impact of a change, collect the right reviews and signatures, and assign training before the new version is released for use.
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
Your validation evidence, including IQ/OQ and PQ records, can be attached to the change record for your approvers to review before release.
What goes wrong today3 common problems
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.
Everything V5 does here5 capabilities
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
Your validation evidence, including IQ/OQ and PQ records, can be attached to the change record for your approvers to review 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.
How it works, step by step6 steps
A change in V5 has one lifecycle, one record, and gates that cannot be bypassed.
- Change opened. Initiator names the object; system computes the impact scope from live linkage.
- Risk-tier and route. Risk tier drives CCB path and SLA; regulator-notification tasks emitted.
- Validation and training deliverables set. V-model deliverables and curriculum reassignments listed as gates.
- Gates cleared. Deliverables signed; training complete; change moves to effective.
- Kiosk sees the new version. Only after every gate closed.
- Post-implementation review. Effectiveness signal captured; unintended consequences surface as CAPA if present.
What to look for when choosing
Change control fails when the impact assessment is a check-box, not a live scope. These criteria separate change control that prevents surprises from change control that documents them after.
Live impact scope
Does the system compute impact from live linkage — SOP → recipe → equipment → training → supplier — rather than asking the initiator to list it? Scope is computed from live relationships; the initiator confirms or adds, but the system won't miss a linked object.
Validation and training gates
Are training reassignment and validation deliverables mandatory gates before effective date? Change cannot become effective until validation deliverables are signed and training is complete.
CCB routing by risk
Are routing paths risk-driven (major/minor, GxP/non-GxP), not one-size-fits-all? Risk-tiered routes with SLA and escalation.
Post-implementation review
Is a post-implementation review scheduled and enforced? PIR is a first-class record with SLA and effectiveness signal.
Regulatory notification tracking
Does the system track downstream regulator notifications required by the change? Notification tasks emitted per jurisdiction with due-date tracking.
V5 compared with other approaches
How V5 change control compares to a Word template and to a legacy change module.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Live impact scope | Author-listed | Author-listed | Computed from live linkage |
| Training gate before effective | None | Optional | Mandatory |
| Risk-tiered routing | Single path | Configurable | Native risk tiers with SLA |
| PIR | Rare | Manual | Native record with SLA |
| Regulator notifications | Missed | Separate tracker | Emitted with due dates |
Regulations this supportsYour quality team stays responsible for compliance
Change control is called out in Q10, GMP, QSR and 13485. V5's design maps directly.
ICH Q10 §3.2.3
Live scope + PIR are the assurance mechanism.
21 CFR 211.100(a)
Procedure changes flow through change control with training gate; execution is documented at time of performance via kiosk.
21 CFR 820.70(b)
Verification/validation deliverables are gates on effective date.
EU GMP Chapter 1 §1.4(xv)
Formal system with risk-tiered routing and post-implementation review.
Standards referenced
- 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)
Common questions3 answers
- 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.