PlatformChange control
Change control software that routes every change by risk
QMSdesk™ change control software sends every change to the right approvers as soon as its impact is known. Your team spends its time on the change itself, not on finding out who needs to sign.
CC-003
Revise storage temperature monitoring, SOP-022
Workflow
Step 4 of 7: Approval
- Origin
- CAPA-001, raised at plan approval
- Approvers
- Change Manager and Quality Manager
- Verification
- By someone other than the implementer
What changes for your team
01
Approvals find their own way
Rate the impact and QMSdesk routes the change. A low- or medium-impact change goes to your Change Manager. A high-impact change needs your Change Manager and your Quality Manager, both signing.
02
A change is never quietly downgraded
Classification can raise a change's tier but never lower it. Anyone with approval authority can add an approver, with a recorded reason. Nobody can remove one.
03
Independence you don't have to police
The person who requests a change can't approve it. The person who implements it can't verify it. QMSdesk checks both at the moment of signature, so your SOP holds even on a busy Friday.
GMP change control, from request to verified
Say a process engineer wants to change a mixing time on Monday morning. Here is the path the change takes.
Step 1 of 7
Draft
The engineer describes the change and submits it.
Step 2 of 7
Triage
It is classified and assigned an impact level, which sets the approval route.
Step 3 of 7
Assessment
The impact and risk are assessed and recorded.
Step 4 of 7
Approval
The routed approvers sign, each re-authenticating, and each signature records its meaning.
Step 5 of 7
Implementation
The work is carried out, with action items that have their own owners. Training for the affected roles is assigned here.
Step 6 of 7
Verification
A different person verifies the work and signs.
Step 7 of 7
Closed
The record is complete, linked and permanent.
A change can also be put on hold, rejected or cancelled, and each of those states is recorded. A step that runs late escalates up a reminder ladder, from the owner to the coordinator to the Quality Manager, so nothing sits unnoticed.
Change control software highlights
The sign-offs your change control board expects, enforced
Your approval matrix is a floor, not a suggestion. High-impact changes always reach both the Change Manager and the Quality Manager. When a change touches something only one expert understands, you can add that expert. The routed approvers stay on the record.
Change raised straight from your CAPA
When a CAPA's action plan is approved, QMSdesk raises the linked change control and the training automatically, before implementation starts. The change carries its origin with it, so anyone can trace the fix back to the problem it solves.
Training follows the change
When a change affects how people work, training for the affected roles is assigned on implementation. It sits in each person's My Work list, with the change it came from.
Your eQMS is under change control too
After go-live, settings that affect validation can't be written until an approved change control reaches implementation. Your validated state stays stable, and every configuration change has a signed record. See how go-live and post-go-live change control work.
Feature index
Everything in change control
Lifecycle and routing
- Seven-stage lifecycle: Draft, Triage, Assessment, Approval, Implementation, Verification, Closed
- On-hold, rejected and cancelled states
- Risk-based approval routing by impact level
- Classification that can raise the tier but never lower it
- Approvers that can be added with a reason, and never removed
- Change actions, each with an owner
Separation of duties and signatures
- The requester cannot approve their own change
- The implementer cannot verify their own work
- Separation of duties checked when each signature is applied
- Re-authentication at every signature, with MFA where your tenant requires it
- A controlled vocabulary of signature meanings
- The signature and the change it approves committed in one transaction
Connections
- Change control raised automatically from a CAPA's action-plan review
- Training assigned automatically on change implementation
- Typed, attributed links to any other record
- Change control on validation-affecting QMSdesk settings after go-live
Oversight and records
- Step deadlines with escalation up a reminder ladder
- Every change in My Work and the cross-module review queue
- Global search across changes and every other record type
- Configurable numbering that is never reissued
- A hash-chained, insert-only audit trail on every action
- REST API access to change records
One connected system
Connected across QMSdesk
CAPA raises the change your corrective action needs.
Training management assigns the training that implementation requires.
Document control holds the SOPs your change revises.
Risk management keeps your change routing proportionate to risk.
Regulations
Regulations it's designed to support
- ICH Q10. Change management and CAPA are peer elements of a pharmaceutical quality system (§3.2), and QMSdesk models them that way.
- ISO 13485. QMSdesk is built to support organizations working to ISO 13485:2016, including controlled, verified changes.
- FDA QMSR. It incorporates ISO 13485:2016 by reference.
- 21 CFR Part 11. Change approvals use controls for Part 11 electronic signatures.
Questions buyers ask
Can someone lower a change's risk level after triage to get a faster approval?
No. Classification can raise a change's tier but never lower it. Approvers can be added, never removed, so the route a change was given is the minimum it gets.
Who approves a high-impact change?
Your Change Manager and your Quality Manager, and both must sign. Low- and medium-impact changes go to your Change Manager.
Does training get assigned when a change is implemented?
Yes. When a change affects training, QMSdesk assigns it to the affected roles on implementation. It appears in each person's My Work list, linked to the change.
Can a CAPA raise a change control automatically?
Yes. Reviewing a CAPA's action plan raises the linked change control and training before implementation starts.
Are changes to QMSdesk's own settings controlled after go-live?
Yes. Validation-affecting settings can only be written after an approved change control reaches implementation.
Every change, on the right desk
Bring one change you're working through today. We'll show you QMSdesk routing it, signing it and closing it.