The change control process is typically defined by a procedure or set of procedures where a change request is initiated. The change request is reviewed and is either approved, or rejected.

If the change request is approved the proposed change plan is implemented via a change order.

Once the change plan is complete the change order is closed and the change has been completed.

Rejected

If the change request is rejected the originator is notified and the originator may abandon the change, or obtain more evidence that the change is beneficial and submit a new change request.

Elements of the change request should include:

1. A description of the change
2. The intended effect of the change
3. Disposition of product (will existing product be modified, disposed of, or used as it is)
4. References to evidence supporting the impact of the change
5. Any required changes to the risk assessment or at the very least a review of the risk assessment
6. A review of the input requirements, and product intended use
7. Any impact to regulatory filings
8. Any required validation activities
9. A detailed plan of what documents will need to be updated

Reverification

The change control process should always include re-verifying and revalidating the design or at the very least a very good justification including evidence of why it it’s not needed.

Depending on where in the product lifecycle the design is the level of re-verification and revalidation will vary