Once a draft document has been created, the next step of the Document Lifecycle is to send the document for review. This is an optional, but collaborative step, when document reviewers and other Quality users can view the document, make suggestions and comments for the document author, and view and reply to other’s comments and suggestions.

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The option to send the document for review will only be present if Reviewers were selected in the document properties. Reviewers can be added to documents created using the New Document or Upload option. For more help on adding Reviewers, see Step 1 of creating a new document.

There are two ways document authors can send a document for review.

Designated reviewers will be notified by email that a document is ready for their review. The document will display on the reviewers Dashboard under the “Your Actions” section. Alternatively, reviewers can browse to the document from the Document Workspace by selecting “Your Actions” and “For Review”. Click on the document to open and view the document.

Once the review is complete, click the Mark as reviewed button. The document author will receive an email notification once all reviewers have completed their review.

For documents created using the Qualio editor, reviewers can take advantage of collaboration features like suggesting edits and inline, real-time comments to collaborate with multiple colleagues on a document. Documents using the Upload format can be commented on, but these comments will appear in the order created in the right margin. The Collaboration Lifecycle image below describes who can do what type of collaboration in the different phases of a document. It’s worth noting that if collaboration leads to a document needing updates, it must be reverted to draft.

Qualio Document: To add a comment to a document’s text, table or image, first highlight the text, then click the comment icon to the right of the text. Enter your comment in the box provided, then click the checkmark to save. While commenting is most likely to occur during the Review phase, document authors can add comments to text while viewing or editing their draft documents prior to sending the document for review.

Note: Comments cannot be added to section headers.

Upload Format: Unlike a document created directly in Qualio, in-line commenting is not available for this format. Comments will be listed in the right margin in the order they were created.

OneDrive Integration: Just like the Upload format, comments can be made and are listed in the right margin in the order they were created.

Comments are visible in real-time to other users viewing the same document. Who and when the comment was made is recorded with the comment. If the window is too small for the main comments box, then the comment will appear under the comment icon on the right.

Comments will remain with the document when it is sent for review or approval, and if it is reverted to a draft. The creator of a comment can edit and resolve their comment, but not delete it. When comments are resolved, they can still be accessed in the Comment History of the document by the owner or Quality user.

1: Refers to Quality Users other than the document author, if the document author is a Quality User.

2: Only if they are the creator of the comment.

Comments can also be added to a document’s Properties tab, Change Control tab, or Training assessment, and reviewers and approvers should remember to check these locations for conformance as well. The comment functionality in these locations, however, is different from the Document Content tab; it uses our old-style of commenting which allows for comments to be resolved, but NOT edited. Otherwise, the permissions listed in the table above are the same.

To add a comment to these locations, you’ll need to be in Edit mode. Browse to the desired tab and click the Add a comment button at the bottom of the page or section. When finished commenting, click Done editing.

If you’re using our OneDrive integration for your documents, you have a choice of reviewing within Qualio or through Word.

In Qualio, you benefit from the notifications sent to reviewers and approvers and full visibility of comments and changes made.

If you carry out the reviews in OneDrive, then you will still want to provide your auditor with information on the reviews given via comments. You may choose to upload a version of the document with track changes visible as a PDF attachment to the document change control to bring what’s happened outside of Qualio into the eQMS.

The ability to suggest inline and real-time changes in a document is a new feature added to Qualio in Q3 2022 that significantly aids document collaborators. Now, colleagues can work asynchronously on a document’s text and formatting because each suggestion is date and time stamped along with the user’s name to provide document authors with greater context on who and when suggestions are made.

When users are in Suggesting mode, inline inserts are highlighted in green, removals are highlighted in red, and formatting changes are in blue.

Each suggestion has a related details notation to the right of the suggestion containing the author and date/time stamp as well as the functionality for collaborators to reply to the suggestion and where document authors can accept or discard changes. But note that Document owners must be in edit mode on Draft documents to accept or discard changes. And all suggestions need to be either accepted or discarded before sending the document for Approval.

1: Refers to Quality Users other than the document author if the document author is a Quality User.

2: Only if they are the creator of the suggestion.

You can view the entire collaboration history of a document, including comments and suggestions as described above. Owners and Quality users have access to view this history by selecting the More Actions button in the upper right corner of the document and then clicking Show Comment History.

The history can be viewed by the document owner and Quality users at any document stage, including Effective documents in the Library.

Reviewing a document is important teamwork based on the idea that four eyes are better than two. Organizations may provide a checklist of items to review or check for in their Document Control policy and procedure. Below are some ideas, contributed by our team of Quality Experts, to consider adding to your document review procedure.

Often, the review phase is iterative, and document authors and reviewers will need to go through several iterations before a document is ready to send for approval. The visual flow below demonstrates the actions and decisions of the review cycle.

Use these links to help you manage documents in a Review status:

Once a document has been fully reviewed, the next step is to send the document for approval. Learn about approving documents by clicking the button below.