Change Control
Every change assessed, approved, and closed
Manage planned changes across documents, equipment, processes, and systems. Impact assessment, cross-functional approval, implementation tasks, and effectiveness checks in one workflow.
Overview
Why change control matters
Every regulated site changes constantly — documents, equipment, suppliers, processes, systems. What regulators expect is proof that each change was assessed for impact, approved by the right people, implemented as planned, and verified as effective. Zixov Change Control makes that entire lifecycle one connected workflow instead of a form that goes quiet after approval.
Change requests are classified and risk-rated at intake, then routed for cross-functional impact assessment: quality, production, engineering, regulatory — each function records its assessment on the same record. QA gates control approval, and implementation is broken into tracked tasks with owners, due dates, and verification evidence.
Nothing closes on good intentions. Post-implementation effectiveness review is built into the workflow, and every linked document revision, training assignment, deviation, and CAPA stays connected to the change — so the full story is visible on one screen, in the order it happened.
60%
faster change cycle times
100%
of changes with completed effectiveness checks
0
approved changes lost in implementation
Typical outcomes reported by teams moving from paper and spreadsheet-based processes to Zixov.
See it in action
Change Control inside Zixov
A look at the actual screens your team will work in — pick a view or let the tour play through.
Every change classified, risk-rated, and visible from initiation to closure.
Challenges we solve
The problems this module was built to fix
Changes approved but never finished
Paper change controls go quiet after approval. Tracked implementation tasks with owners and due dates make sure approved changes actually land.
Impact assessments miss functions
Ad-hoc email assessments skip departments. Structured cross-functional routing guarantees every required function assesses and signs before approval.
No proof of effectiveness
Regulators ask how you know the change worked. Built-in effectiveness review with evidence closes that gap before the record closes.
Fragmented change history
Related documents, deviations, and CAPAs live in separate binders. Linked records keep the complete context of every change in one place.
Capabilities in depth
What CCM does, in detail
Intake & risk classification
Capture change requests with structured classification, risk rating, and regulatory impact screening — so effort scales with risk.
- Configurable change categories and risk matrices
- Regulatory impact screening questions
- Like-for-like fast paths for low-risk changes
Cross-functional impact assessment
Route the change to every affected function in parallel; each records its assessment, required actions, and sign-off on the same record.
- Parallel assessment routing by function
- Document, training, and validation impact identification
- Consolidated assessment view for approvers
Approval & implementation
QA-gated approval releases a plan of tracked implementation tasks, each with owners, due dates, evidence, and verification.
- Multi-level approval with QA gate control
- Task plans with dependencies and escalations
- Implementation evidence attached per task
Effectiveness & closure
Schedule post-implementation review, record effectiveness evidence, and close the change with QA sign-off and the full linked history.
- Scheduled effectiveness checks with criteria
- Linked deviations, CAPAs, and document revisions
- QA-controlled closure with e-signature
How it works
The change control lifecycle in Zixov
Initiate
Raise the change with classification, justification, and risk rating.
Assess
Affected functions evaluate impact in parallel and define required actions.
Approve
Approvers see consolidated assessments; QA gates the decision.
Implement
Tracked tasks execute the change with evidence and verification.
Verify & close
Effectiveness review confirms the change worked before QA closes the record.
At a glance
Everything included
Change request initiation with classification and risk rating
Cross-functional impact assessment routing
Approval workflows with QA gate control
Implementation task tracking and verification
Post-implementation effectiveness review
Linked documents, deviations, and CAPAs for full context
FAQ
Common questions about change control
Can the workflow match our current change procedure?
Yes. Change categories, assessment functions, approval levels, and QA gates are configurable, so the system enforces your SOP rather than replacing it.
How are document changes connected?
A change record can spawn linked document revisions in the DMS; the change can't close until the linked revisions are effective and any triggered retraining is complete.
Do low-risk changes have to go through the full workflow?
No. Risk-based routing lets like-for-like and low-risk changes take an abbreviated path with reduced assessment and approval steps — documented and justified in the record.
What visibility does management get?
Dashboards show open changes by status, age, and risk class, overdue tasks, and effectiveness-check results — the inputs your management review needs.
Better together
Works together with
Change Control is one part of a connected quality suite — records flow between modules automatically, so nothing is re-entered and nothing falls through.
See Change Control in a live demo
30 minutes, tailored to your workflows — bring one of your own processes and watch it run in Zixov.