This article is your guide to understanding how documents move through the account. We'll explore each key step, from when a document is first a Draft, through its Draft Review and becoming Reviewed, all the way to being Approved and made Effective. Finally, we'll cover what happens when a document is ready for the Retirement process.
This overview will focus on:
Draft Document
Draft Review Options
Reviewed Status
Approved & Effective Documents
Minor & Major Revisions
Rejected Status
Retirement
Draft Document
Creating a New Document
Click the green plus button at the top of the screen. Select document:
A new screen will open to add the document information. Add the document name, category assignment, target approval date, and mark if this is a training item. Click create when finished:
Uploading a File and Filling in the Metadata
After a new document is created, you will be directed to the document view screen. This screen is divided into three sections:
- Document Viewer: A PDF rendering of your file will display here.
- Document Metadata: Document settings and configurations are listed here.
- Document Panel: A panel of functions that can be executed on the document.
Document Viewer
- PDF File Viewer: The file will display here.
- Panel: Can be used as a table of contents.
- PDF View Controls: Page transitions, layouts, & orientation is adjusted here.
- Zoom Options: Zooms the PDF viewer in and out.
- Toggle: Can be toggled to full screen.
- Search: Search the metadata within the file.
- Settings: Can change the view between light mode and dark mode.
Document Metadata
The document metadata section lists the settings for the document. These settings are configured at the document category level, but can be changed at the individual document level:
The settings in this section are as follows:
- Upload File Revision: Here is where the file is uploaded.
- Collaborative Editing: Here is how a collaborative editing session can be started for this file.
- Authors: Authors are listed here. Additional authors can be added from the dropdown; there is no limit on author assignment.
- Name: Document name; must be unique.
- Category: The category that the document is assigned to is listed here. Once the category is selected it can not be changed, even if the document is in a draft state.
- Document ID: This is the ZenQMS legacy id number.
- PDF Header with Document Data: Choose to have a header on the document or not here.
- Document Security: There are four settings to choose from: Users Can Download Original File, Users Can Only View Document, Users Can Download a Unrestricted PDF, & Authorized Users Can Issue Controlled Copies.
- Effective Date: There are three options to choose from: Based on Target Date, Based on Days From Approval, & Based on Training %.
- Target Approval Due Date: This is the date that is targeted for the document to be in an approved state.
- Description: Description of the document.
- Version Comments: Version comments are added here.
- Document Review Interval: This interval is the timeframe that the document will come up for review.
- Show/Hide Training Fields and Assignments: If this is a training document, toggle the button on. If this is not a training document, leave the toggle off.
- Automatically Create Training Records for Authors/WF Participants: Training records will be created for the author and all workflow participants when a new revision is approved/effective.
- User Retraining Interval (months): Assigned trainees' retraining interval.
- Custom Fields: All custom fields made at the category level will be displayed here.
- Links: Documents can be linked to other internal items.
Document Panel
The document panel lists action items that can be done at the document level:
1.Download: Users can download various levels of the file based on permissions.
2.Workflows/ E-Signature History: Workflow and Signature history is captured here.
3.Training: Trainees and training challenge questions are added to on the item here.
4.Version History: Draft and published version history is captured here.
5.Review and Suggested Edits: Suggested edits and periodic reviews are captured here.
6.Controlled Copies: Authorized users can issue controlled copies here.
7.Chat Log: Document chat log.
Add a file by clicking 'Upload Revision'. Once uploaded, the document can be seen in the viewer on the left.
Draft Review Options
Launching a Draft Review
Draft reviews are initiated by clicking the 'Launch Draft Review' button, once the file is added.
There are 3 draft reviews options that will display in the slider:
- Sequential Draft Review: Draft Reviews with Sequential Reviewers
- Collaborative Editing with Simultaneous Reviewers: Draft Review: Collaborative Editing
- Annotate on Screen Editing with Simultaneous Reviewers: Draft Review: Annotation Editing
As a note, a document does not need to go through a draft review to become approved/effective. This is optional.
Reviewed Status
If the draft document does not go through any type of review, it will never be in a reviewed status.
Once all of the reviewers completed their portion of the draft review, the document status will change to 'Reviewed'.
The author can review the review information left by the reviewers and update the source file accordingly. Once the final, clean version of the file is ready you can import it by clicking 'Upload Revision' again. Now the document is ready to be launched for approval.
Approved & Effective Documents
Approved Documents
If the document's effective date is in the future, once all workflow signatures are submitted the document will stay in this state until the effective date; the document will change states (from approved to effective) automatically.
Minor & Major Revisions
Versioning of documents typically involves differentiating between minor and major revisions based on the extent of changes made to the document. When users are up-versioning their documents, they may choose either type.
Minor Revisions
Note: Minor revisions involves relatively small or incremental changes to the existing document without fundamentally altering the process or procedures. These changes do not require retraining nor update the Review Date.
Minor revisions are used when the changes made to the document are minimal and typically do not alter the document’s intent or content significantly. You would up version a document to a new minor version (e.g., from 1.0 to 1.1) when you make minor changes that do not fundamentally alter the document's purpose or implications. This is often done to reflect corrections, updates, or minor enhancements.
To complete a minor revision on a document, click the review/retire button:
In the document window, make the appropriate mark ups, add the supporting comments, and then click Item Must be Updated - Minor Revision:
You will then be prompted to sign off as the document reviewer and the document will need to complete the Periodic Review workflow, if you have one configured. After the document reviewer and the periodic workflow is completed, the draft document will be created.
In the new draft, the minor revision numbering will be reflected at the top of the document management window:
Fill in the document metadata that needs to change and add a new file, if needed. Once the document details are filled in, click Launch Approval Workflow.
Since this a minor revision, the document will go through the minor revision approval workflow that is configured at the document category level:
After the approval workflow signatures are completed, the new revision will be approved/effective and housed on the documents full table. It will have the minor revision version number:
Major Revisions
Major revisions are applied when substantial changes are made to the document that affect its intent, content, or scope significantly. A major version change (e.g., from 1.0 to 2.0) is appropriate when there are significant changes that impact the document’s core content, purpose, or compliance requirements.
When a Major Revision is completed, the users assigned to training will be required to retrain (if the setting "Immediate Retraining Required" is toggled ON). The new document review date will be updated based on the new effective date + document review interval.
To complete a major revision on a document, click the review/retire button:
In the document window, make the appropriate mark ups, add the supporting comments, and then click Item Must be Updated - Major Revision:
You will then be prompted to complete the Periodic Review workflow, if you have one configured. After the workflow is complete the new draft will be created.
The new draft's major revision numbering will be reflected at the top of the document management window:
Fill in the document metadata that needs to change and add a new file, if needed. Once the document details are filled in, click Launch Approval Workflow.
Since this a major revision, the document will go through the major revision approval workflow that is configured at the document category level:
After the approval workflow signatures are completed, the new revision will be approved/effective and housed on the documents full table. It will have the major revision version number:
If the document is in the approved state, the new, next document review date will be blank in the documents full table and will also be missing at the document level. This information will auto populate once the document is in the effective state.
Rejected Status
If, during the minor or major approval workflow, one of the approvers rejects the flow, the document will move into a 'Rejected' status and the workflow will stop. The author will need to cancel the workflow and start again.
Retirement
Documents become obsolete due to updates in regulations, processes, or technology, or if it has been superseded by a newer version. Retirement is also necessary when the document is no longer needed for regulatory compliance or has reached the end of its lifecycle as per organizational policies. Additionally, documents that are redundant or duplicated elsewhere may be retired to streamline documentation. Proper archiving for historical reference can be ensured in the application.
To retire a document, in the viewer/management window, click Review/Retire:
You must add a comment to the document first, then click Item is Obsolete:
A slider will open to start the review and retirement process. First, select the user that will complete the periodic review step. Then click on 'Configure Retirement Workflow'.
Add the user(s) needed to complete the retirement workflow step. Once filled in, click on 'Launch Workflows'. You may go back up to the previous box to change the periodic review step information by clicking 'Configure Review Workflow'.
After the document goes through the retirement workflow, the item will be in the retired status:
All retired documents, that were not permanently deleted, can be accessed on the documents archive table. To access this table, go to the documents module and select Documents: Archive Table from the dropdown:
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