NEW DOCUMENT EDITOR MESSAGE

This article includes images and features of the new Document Editor to be released to all Production accounts at the end of the 30-day Validation period, approximately February 27, 2023. Validation information has been sent to Quality Users in your organization. Click here for tips on how to transition to the new editor. For questions, please contact your Customer Onboarding Manager or the Support Team.

Managing an organized document stack means investing time and energy in the updating, tagging, exporting, and updating ownership of documents. We’ll discuss all functions related to document management in this article.

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Edit or Upversion documents

Some documents, once created, will never need to be changed. But inevitably, many documents will change and evolve over time as your organization and products grow and develop. You’ll hear and see different terms for the updating of documents based on the current phase of the document. Below are instructions for editing drafts, reverting documents to a draft status, and up-versioning effective documents.

Edit a Draft Document

A document can only be edited by the owner/author of that document, and only Normal and Quality users can create/edit documents. If you need to edit a document you do not own, you’ll need to change the document ownership.

First, identify the draft document by browsing to the Document Workspace and filtering for Your Documents in a Draft status.

  1. Select the document you wish to edit.

  2. By default, you’ll be in Viewing mode when the document is opened. Click the mode button and change to Editing.

  3. Make changes to the document content, properties, change control record and training assessment.

  4. When finished, click the Done editing button.

Document authors can add comments to text while viewing or editing their draft documents prior to sending the document for review. Learn more about adding comments here.

Note: All changes are saved automatically to prevent the loss of work in case of network disruption.

Revert Documents to Draft Status

Once a draft document has been sent for review or approval, you should consider the draft as “locked” and cannot be edited without reverting the document to a Draft status. Reverting a document to draft status will require the document to be resent for review and/or approval.

However, if a reviewer or approver leaves a comment for the document author, the document does not need to be reverted to draft in order to reply to the comment.

To revert a document to draft, first, identify the document by browsing to the Document Workspace and filtering for either Your Documents or All Documents (Quality users can revert documents they don’t own back to Draft), and either the For Review or For Approval status.

Then, you can mass or single select documents from the Workspace by checking the box and clicking the Revert to Draft button, or you can click the individual document to open and click the Revert to Draft button from that view.

You can then edit the draft document as described above.

Upversion an Effective Document

Effective documents must also be put into a draft status before editing so that any changes to the document can be reviewed and/or approved. Both Quality and Normal user roles can create a new draft from an effective document, aka upversion.

First, identify the effective document by browsing to the Document Workspace and filtering for either Your Documents or All Documents in an Effective status.

Then, you can mass or single select documents from the Workspace by checking the box and clicking the Create New Draft button, or you can click the individual document to open and click the Create New Draft button from that view.

You can then edit the draft document as described above.

Change Control Records

Qualio uses a built-in Change Control form to assist users with logging all document changes. The form is presented on the Change Control tab of the document. As you manage, edit, and upversion your document stack you may need to investigate change control (CC) records, and you’ll need to understand when and how new CC records are created and closed.

A new CC record is created and related to every new draft document. And just like the document it is related to, it can only be edited when the document is in a draft status. Once the document is sent for review and/or approval, both the document and CC record are locked. If the document needs to be reverted to a draft status for further revisions before being approved and made effective, then the related CC record will also be unlocked allowing users to add to the CC record.

When a document is made effective, the related CC record will be closed and cannot be reopened or modified. If a new version of the document needs to be created, a new CC record will be created and related to the new draft document.

CC records can be viewed and opened from either the document’s Change Control tab, or by opening the Change Control Report which lists all CC records with creation and closed dates. Click here for more information about the Change Control Report.

An organization’s Change Control form is controlled by the Change Control Template and can be modified by Quality Users. Additional CC templates cannot be created. To view and/or modify your CC template, browse to the Organization Settings. Select Change Control on the left-side menu, and click the Change Control Template to open.

Similar to document templates, sections can be added, removed, and moved around on the change control template to meet your organization’s requirements.

Compare Versions of a Document

When managing a document through multiple updates and versions, it can be helpful to view a document against previous versions of that document. However, documents cannot be edited while comparing versions.

When viewing the document, you can select which version to display and which version to compare it against using the two respective buttons. New content will be highlighted in green and removed content will be shown in red.

A document’s version number is automatically incremented (starting at 1) and controlled by triggers within the document lifecycle to update either the major or minor version.

  • Major Version

    • Whole number before the decimal point. Example: 4.0 represents the fourth major version of a document.

    • Increments are triggered when a document is approved.

  • Minor Version

    • Decimal number to the right of the decimal point. Example: 0.2 represents the second minor version of a document.

    • Increments if the document is put back into draft status after being sent for review or approval.

Export Documents

Single documents can be exported to PDF, and document list views can be exported to either PDF, CSV, or XLSX. Bulk downloading PDF documents is not currently available but something our Product Team is investigating.

Every user has the ability to export a single Qualio document to PDF. However, there are two export options depending on the user’s role and the status of the document: Controlled or Uncontrolled copy.

  • Controlled Copy

    • Can only be created by Quality users

    • Can be considered as the “master” copy; often used in lab settings where a copy must be printed and kept in a binder for easy reference.

    • Can only be created from effective documents

    • “Controlled copy” identified in the PDF footer

  • Uncontrolled Copy

    • Can be created by Basic, Normal, and Quality users

    • Can be used as personal copies for things like note-taking.

    • Can be created from a document in any status.

    • “Uncontrolled copy” identified in the PDF footer.

To export a single document to PDF, start by opening the document and clicking the Export button. From the options dialogue box, select the type of copy (if applicable), the page orientation, and if a cover page should be included. Then click the Export Document button and the PDF will be auto-downloaded.

The PDF header includes the document name, ID, and version number. It is possible to export a previous version of a document by first selecting the version to display then follow instructions to export above, however, a “Superseded document” watermark will appear across all pages of the pdf.

The cover page provides helpful information including the author, reviewers, approvers, approval and effective dates, and next periodic review. Your organization’s logo will also be included if it has been setup in the Organization Settings.

Note: PDF headers. footers and cover page cannot be modified.

Users can also export lists of documents that function as an index, from either the Document Library or Workspace. Targeted lists of documents can be created using different status, ownership and tag filters.

Alert! Whatever documents display in the Workspace after filtering
will be the same documents exported.

If the export is taking too long, users can continue to work in Qualio. You'll be notified with export is ready for download.

Change Ownership

As users, roles and responsibilities change in your organization, so will document ownership. Not only does document ownership allow you to edit a document, but as the owner, you’ll receive notifications of new comments, upcoming periodic reviews, and other crucial document lifecycle updates.

While bulk ownership changes are easy within Qualio, this does not have to precede a user’s removal/termination because the user removal process already prompts for the reassignment of documents and events.

Only Quality users can change a document’s owner to either themselves or another Quality or Normal user.

To change a document’s owner, first identify the document by browsing to the Document Workspace and filtering for All Documents and the correct document status, or use the search bar.

Then, you can mass or single select documents from the Workspace by checking the box and clicking the Change Owner button. Select the new owner from the dropdown and click OK.

Document ownership can also be changed when viewing the individual document and clicking the More Actions dropdown. Select Change Owner, then select the new document owner from the dropdown and click OK.

Document Owner vs. Author

As you create and engage with documents in different phases, you’ll see that document authors and document owners are identified, but what is the difference?

  • Document Author: The user who owns the document in its pre-approved status. This user/owner will send/sent the draft document for approval.

  • Document Owner: Can be changed after a document is approved, while maintaining the initial author. Note: Any normal or quality user can still create a new draft from an effective/approved document.

It is very common to see a department/Quality Manager as the document owner of all approved documents, although many documents are created and contributed by other department members.

Delete Drafts

Part of managing your document stack may include the deletion of draft documents and retiring of effective documents to keep your Document Workspace neat and tidy. Normal and Quality users can delete draft documents they own by opening the document and clicking the More Actions button, then selecting the Delete option.

You’ll be prompted to confirm your action and the impact it will have on your document. Deleting a draft will revert the document to the most recently effective version. Example: If draft version 4.3 is deleted, minor versions 4.1, 4.2, and 4.3 will be deleted. All 3 minor versions can be accessed from the Deleted Drafts section of the Document Workspace. See below for restoring deleted drafts.

Restoring Deleted Drafts

Deleted drafts will be retained in Qualio for 90 days. Normal users can recover deleted drafts they have created. Quality users can recover any deleted draft, regardless of ownership.

Deleted Drafts can be recovered by:

  1. Browse to the Document Workspace and select the Deleted Drafts status. Select the appropriate ownership filter (Your Documents or All Documents).

  2. Select the document to be recovered and open/view.

  3. Click the Undo Delete button in the upper left corner of the document.

  4. The document will then be displayed in the Document Workspace as a Draft.

Once the undeleted document is approved, any formerly deleted drafts will no longer be available in the “Deleted Drafts” area of the Document Workspace.

Next Steps

Looking for more information about documents? Try some of these options:

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