Review and approval

TraceX includes electronic signatures (21 CFR part 11, FDA), which are used for reviewing and approving documents.

Reviewing a document

To send a document for review, click Send for review and select the members that will be reviewing the document. This menu will automatically populate with the reviewers selected when creating or editing the document, but you can add additional reviewers here as well. Then, click Send.

Document reviewers will be able to add their electronic signature when submitting their review.

After the document has been reviewed, any further edits will be recorded for comparison. Selecting the Comparing option will allow you to view the edits to the document, using red and green highlights to show deletions and additions.

Approving a document

To send a document for approval, click Send for approval and select the members that will approve the document.

Note: All comments need to be resolved before sending a document for approval. If unresolved comments remain, the Send for approval button will be disabled.

Once sent, the approvers can approve or reject the document and add their electronic signature.