
What the form covers
The workbook walks 15 steps across the change lifecycle — PROPOSE, ASSESS, APPROVE, IMPLEMENT, CLOSE — one workbook per change, each step with response, evidence-reference, owner, date and status columns (Open / In progress / Complete / N-A dropdown), plus an Instructions tab and a worked example.
- Change description, rationale and major/minor classification
- Impact assessment: product quality, validation, regulatory, documents, training
- QA approval before implementation, with conditions recorded
- Implementation through document control with training completed first
- Post-implementation review and effectiveness evidence before closure



