A writer can use an Approval to get a final sign off on content once all the reviews are complete.

Reviewers use the Approval to see the finished content and then let the writer know if they approve the final version. Or if something requires more work, they can reject it and provide feedback to the writer on what needs to change.

Approvals using FDA standards

The Approval feature in IXIASOFT CCMS Web can be integrated into a system that meets U.S. Food & Drug Administration (FDA) requirements for electronic documents and digital signatures. Approvals have the required technical controls to be part of a 21 CFR part 11 compliant system.