How to Manage Document Versions and Modifications in the Document Control Process

Martine Boire
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Environment

  • Product: SOLABS QM10
  • Process: Document Control QM Application (QM APP)

  • Affected Versions: All versions

     

Issue / Symptoms

 

Users working with the Document Control Process may encounter unexpected behaviors when attempting to:

  • Link a document to multiple active Document Control processes simultaneously
  • Modify the scope or content of a document already engaged in an active process

 

The following error message may appear when attempting to link a document already associated with an active QM APP to a new Document Control Process:

Error: Document is already linked to an active Document Control Process.

Cause

 

The Document Control Process in SOLABS QM10 enforces a one-to-one relationship between a QM APP and a specific document version. This constraint is by design to preserve document integrity and ensure regulatory traceability throughout the change control lifecycle.

Resolution

A Document Control Process is always linked to exactly one (1) version of a document at a time.

  • When a Document Control QM APP is initiated for a document (for example, to revise a document currently at version 2.0), the QM APP remains linked to that specific version until it reaches an eligible status.
  • A new Document Control Process cannot be initiated for the same document unless its status within the existing QM APP is one of the following:
    • Approved & Effective
    • Approved, Not Effective

Best practice: Complete the ongoing QM APP and allow the current document version to reach an approved state before initiating a new Document Control Process for the next version.

 

Other Possibilities : 

Removing a Document from an Active QM APP (Steps 1–3 Only)

It is possible to remove a document from an ongoing Document Control QM APP, provided the process has not advanced beyond Step 3. The following steps are eligible:

  1. Step 1 – Change Request for Creation, Revision or Retire of Document Documents can be added or removed directly at this step.
  2. Step 2 – Owner / Manager Approval The QM APP must be returned to Step 1 before the document can be removed.
  3. Step 3 – Document Coordinator Processing The QM APP must be returned to Step 1 before the document can be removed.

After removal, the following outcomes apply:

  • If other documents remain linked to the QM APP, the process can continue for those documents.

  • If the removed document was the only document linked to the QM APP, the process must be cancelled. The following message will display when accessing the Process Task Form:

    This process has been cancelled because no documents remain linked.

    Once cancelled, a new Document Control Process can be initiated for the removed document version.

Alternative to removal — Updating the change request at Step 1:

When the QM APP is at Step 1 (or has been returned to Step 1 from Step 2 or 3), it is also possible to update the Description of Change and Purpose of Change fields to include additional modifications. This allows the document version to remain within the existing process without requiring removal or cancellation.

 

Handling Modifications When the Process Has Advanced Beyond Step 3

If the Document Control Process has advanced past Step 3, it is not possible to remove the document from the process. In this situation, the following options are available:

  1. Modify the Description and Purpose (document not yet approved):
    • Access the active QM APP.
    • On the right-hand side panel, select the Modify Description and Purpose option.
    • Document the additional changes required for that version.
    • Note: This option is only available while the document status is not yet Approved.
  2. Cancel the process and initiate a new one:
    • Cancel the current QM APP.
    • Once cancelled, the document version will no longer be linked to any active Document Control Process.
    • A new Document Control Process can then be initiated and the document selected for inclusion.

⚠️ Important: Cancelling a QM APP should be considered a last resort. The recommended approach is always to follow the standard process flow — approve the current document version, complete the active QM APP, and then initiate a new Document Control Process for the next document version.

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