Infographic: Change Management Steps in Validated Systems
Analyse the requirements, objectives, and impact of the change in addition to assessing the expected outcomes during the project’s design stage.
- Step 1: Assess the Change Request
- Step 2: Assess the Impact
- Step 3: Document the Expected Outcomes
Implement the change in a sandbox or similar safe environment and then test before updating validation documents with new specs, processes, etc.
- Step 4: Implement in a Safe Environment
- Step 5: Test the Charges
- Step 6: Update Validation Documentation
Now move to the live environment to implement the change, test, and re-validate ensuring full record keeping of tests and test results. Finally, train users as required.
- Step 7: Implement in a Live Environment
- Step 8: Testing and Re-Validation
- Step 9: Train Users