Change control form, template and SOP example: what a good one contains

A change control procedure and form do not have to be long. They have to be complete: every step that matters is mandatory, every field has a purpose and nothing relies on the reader's memory. This guide lists what each should contain and shows a short filled-in example. A free editable SOP template that follows this structure is available on this site.

What the SOP should cover

1. Purpose: what the system is for, in one paragraph.
2. Scope and exclusions: what falls inside, what is genuinely like-for-like, and which changes are handled by other procedures such as editorial document corrections.
3. Definitions: change, impact assessment, change owner, effectiveness check, emergency change.
4. Responsibilities: a table of who raises, classifies, assesses, approves, implements and verifies. Quality approval is never delegated to the person doing the work.
5. System requirements: unique accounts, electronic signatures with meaning, audit trail, a workflow that blocks implementation before approval, links to deviations, CAPAs and training.
6. The procedure: raise, classify, assess, approve, implement and verify, check effectiveness and close, with time limits for each step.
7. Emergency and temporary changes: when allowed, who authorises, follow-up deadlines.
8. Records, retention and references to related SOPs and regulations.

What the change request form should contain

• Identification: number, date, site, area, system or equipment, change owner, QA contact.
• Current state and proposed state, by document number, version, model or parameter.
• Reason for the change, with the evidence: deviation, CAPA, trend, obsolescence notice or business case.
• Classification with a written rationale.
• Regulatory assessment against the registered dossier, with the variation category where applicable.
• Impact assessment by area, each with an assessor and a reason for any 'no impact'.
• Approvals, by role, with electronic signature or signature, date and time.
• Action plan: tasks, owners, due dates and evidence references.
• Effectiveness check: criteria, method, date and outcome.
• Closure: Quality conclusion and the date implemented.

The approval and signature block: prepared by, checked by, approved by

The block at the top or foot of a change record, often written 'prepared by, checked by, verified by, approved by', is where the record proves who did what and in which order. Each line needs a role, a name, a signature or electronic signature, and a date and time. In an eQMS the signature must also show its meaning (author, review, approval) and be linked to the record.

• Prepared by: the change owner, who wrote the request and the proposal.
• Checked or reviewed by: the subject matter expert or department head who completed or reviewed the impact assessment for their area.
• Verified by: the person who confirms the tasks were completed and the evidence is attached, independent of the person who did the work.
• Approved by: Quality before implementation, plus the qualified person or responsible person and management for major and critical changes.
• Closed by: Quality, with the effectiveness conclusion, after implementation.

A short filled-in example

Common weaknesses in forms

• A single free-text 'impact' box instead of one answer per area.
• No mandatory regulatory question, so the dossier is never compared.
• Effectiveness left as a date with no criteria.
• Approval fields that the change owner can complete.
• No link fields to the originating deviation, CAPA, documents and training.

For the section-by-section view of the form with the guidance behind each section, see the templates page. For the process the form supports, see the complete guide to GMP change control.