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Archiving a document

Learn how to archive a document.

When to archive?​

Archiving occurs when a document is no longer applicable but must be retained for regulatory, historical, or audit reasons.

Archiving scenarios​

Automatic archiving:

  • When publishing a new version (previous version automatically archived)
  • According to configured lifespan (e.g.: automatic archiving after 5 years)

Manual archiving:

  • Document became obsolete without replacement
  • End of project or application scope
  • Quality department decision
  • Documentation consolidation or redesign

Lifecycle statuses​

Work (In progress) → Valid (Applicable) → Invalid (Archived)
  • Work (W): Document being created or revised
  • Valid (V): Applicable document, official version
  • Invalid (I): Archived document, for historical consultation only

Archiving process​

Who can archive a document?​

Authorized profiles:

  • Document manager
  • QDM administrator
  • Quality manager (depending on configuration)

Manual archiving procedure​

  1. Access the document

    • Search for the document to archive
    • Open its document record

  2. Initiate archiving

    • In the toolbar, go to the Tools menu
    • Click on Archive
    • Or via contextual menu: Actions > Archive

  3. Justify the archiving

    • Reason: Select from options (Obsolete, Replaced, End of project, etc.)
    • Comment: Explain the reason for archiving
    • Replacement document: If applicable, indicate the new reference

  4. Confirm

    • Validate the archiving
    • The document changes to "Archived" status (Invalid)

Note: This action is only available to certain users depending on the rights configuration set up in the application.

Notifications​

Concerned users may be notified:

  • Managers and editors
  • Regular readers (depending on configuration)
  • Impacted services

Consequences of archiving​

Visibility:

  • No longer appears in standard searches
  • Accessible only via advanced search with "Archived" filter
  • Visible in the history of linked documents

Consultation:

  • Document still viewable in read-only mode
  • Download possible
  • "Archived document" watermark applied automatically

Prohibited actions:

  • Can no longer be revised
  • Can no longer be distributed with acknowledgment receipt
  • Modifications blocked (except administrators for exceptional corrections)

Consulting archived documents​

Searching archived documents​

  1. Access document search
  2. Enable Advanced filters
  3. Check "Include archived documents"
  4. Or filter by status: Invalid (I)

Method 2: History​

  • Via a linked or replacement document
  • History or Linked documents tab
  • Archived versions are listed

Method 3: Dedicated view​

  • Menu QDM > Archived documents (if the Archived view is available)
  • Lists all documents in archived status
  • Filters by type, process, archiving date

Archives view

Note: Access to archived documents is generally reserved for application administrators.

Available information​

For each archived document, you can consult:

  • All original metadata
  • Application dates (start and end)
  • Validity duration
  • Archiving reason
  • Replacement document (if exists)
  • Complete history

Download​

Archived documents are downloadable:

  • PDF format with "Archived document" watermark
  • Source file (depending on rights)
  • All attachments

"Obsolete document" message​

In the archived document, a message clearly indicates that the document is obsolete and should no longer be used as an operational reference.

Conservation and regulatory compliance​

Retention periods​

According to regulatory requirements in your sector:

Health sector / medical devices:

  • ISO 13485: Minimum device lifetime + 5 years
  • FDA 21 CFR Part 820: Minimum lifetime or 2 years after distribution
  • EU MDR: Minimum 10 years after market placement

Other sectors:

  • According to applicable regulations
  • Configurable setting by document type

Audit trail​

All archiving history is preserved:

  • Archiving date and time
  • User who archived
  • Reason and justification
  • Subsequent consultations

This traceability ensures compliance during regulatory audits.

Permanent deletion​

Important: Archiving is NOT deletion.

Permanent deletion of a document:

  • Is strictly regulated and tracked
  • Requires administrator rights
  • Must comply with legal retention periods
  • Generates a complete audit trail

⚠️ Warning: Never delete a document without ensuring compliance with regulatory retention periods.

Unarchiving​

In certain exceptional cases, a document can be unarchived.

Unarchiving procedure​

  1. Access the archived document
  2. Verify relevance: Ensure no equivalent document exists
  3. Click on [Unarchive] (administrators only)
  4. Justify the unarchiving
  5. The document returns to Applicable status

Use cases​

  • Archiving error
  • Temporary need for reactivation
  • Cancellation of a replacement project

Warning: Unarchiving must remain exceptional and justified.

Best practices​

Before archiving​

  • Verify that no process still uses the document
  • Communicate the archiving to stakeholders
  • Indicate the replacement document if exists
  • Clearly document the reason

Documentation​

  • Use explicit reasons
  • Add detailed comments
  • Create links to replacement documents
  • Archive communication evidence

Periodic cleanup​

  • Regularly review the document collection
  • Identify obsolete documents
  • Plan archiving campaigns
  • Maintain a coherent and up-to-date repository

See also: