Free change control form template
A Word change control form for GMP and ISO teams, from change request and impact assessment to signed approval, implementation and effectiveness. No email needed.
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Free to use and adapt in your organisation. No email address needed. Add your own document number and version, and approve the form under your document control before use.
- Word (.docx)
Change control form
Current and proposed state, justification, impact assessment, classification, implementation plan, approvals and closure.
What this template is for
Change control makes sure a planned change to equipment, processes, methods, computerised systems, materials or documents is assessed and approved before it is made, and verified afterwards. EU GMP Annex 15, ICH Q10 and ISO 9001 describe the expectation; inspectors test it by picking a change and following it from request to closure.
The form records the current and proposed state side by side, an impact assessment across eleven areas, the change classification, an implementation plan split into actions before and after go-live, the approvals and the effectiveness check.
Requirements it supports
How to fill it in
- 1
Raise the request before anything changes
Give the change a number, an owner and a proposed date. Temporary changes get an end date.
- 2
Describe the current and proposed state
Name the documents, versions, equipment or settings in place today and exactly what will differ, so a reviewer can see the change without asking.
- 3
Assess the impact with the experts
Go through every area: product quality, safety, validation, computerised systems, regulatory filings, documents, training, suppliers, stability, health and safety, and other sites. Write N/A with a reason rather than leaving a row blank.
- 4
Classify the change
Use the minor, major and critical definitions in your procedure, and record whether a regulatory notification or change control board review is needed.
- 5
Plan the implementation
List the actions that must be finished before go-live, such as qualification, document approval and training, and those that follow it, such as verification batches or monitoring.
- 6
Approve, then implement
Each approver records a decision and its meaning. Nothing changes on the floor before QA has approved.
- 7
Verify and close
Confirm that every action is complete with evidence, check that the change achieved its purpose without new problems, and close the change with QA.
Common mistakes inspectors flag
Implemented before approval
Equipment replaced or procedures changed before QA signed the change. This is the first thing inspectors check when they sample changes.
"No impact" without a reason
Impact assessments with every box ticked "no" and no explanation give a reviewer nothing to verify.
Validation impact missed
Changes to equipment, processes or computerised systems without assessing whether qualification or validation must be repeated.
Temporary changes that become permanent
Temporary changes without an end date, or still in place months after they expired.
People not trained before go-live
A revised procedure in use before the people who follow it were trained on the new version.
Do this in QFacts
A template works until the records pile up. QFacts keeps these records in one eQMS with workflows, electronic signatures and an audit trail. Try it for 14 days, no credit card needed.
- Record the current state, proposed state and justification for every change.
- QA assesses the impact, and the change control board approves when needed.
- Every decision is signed electronically.
- An audit trail that cannot be edited or deleted keeps every step from request to closure.
Frequently asked questions
What is change control in GMP?
Change control is the documented process for proposing, assessing, approving, implementing and reviewing changes that could affect product quality, the validated state or regulatory compliance. Its purpose is that no such change is made without a documented assessment and approval.
What is the difference between a minor and a major change?
Your procedure defines it. Typically a minor change has no effect on product quality, validated state or regulatory filings, while a major change could affect them and needs further assessment, testing or validation, and sometimes regulatory notification. Write the definitions down and apply them consistently.
Who should approve a change?
At least the change owner, the head of the affected department and QA. Major changes often go to a change control board, and changes affecting filings need regulatory affairs. The form has a row for each, with the meaning of every signature.
Is a change control the same as a deviation?
No. A change is planned and approved before it happens. A deviation is an unplanned departure from an approved procedure or specification, investigated after it happened.
Is the template free?
Yes. Download the Word file without an email address and adapt it to your own change control procedure.
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