Managing comments and justifications

At each validation step, you have the possibility (sometimes the obligation) to add a Comment.

Usefulness of comments

• These comments are stored in the history.
• They allow you to explain a decision (e.g.: "Approved subject to title modification" or "Rejected due to missing attachment").

Business Case (Quality)

When validating a corrective action plan (CAPA), the Quality Manager verifies the effectiveness of the actions. If they are not convinced, they click on Reject and add the comment: "Insufficient proof of effectiveness, please add the test report". The file then returns to the action coordinator.