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What are approvals?

Document Approval is the formal process of reviewing and signing off on documents within the eQMS. This ensures that documents like Standard Operating Procedures (SOPs), plans, or reports found in the Document Explorer are accurate, complete, and meet the required standards before they become official or “live”. Think of it as a quality checkpoint for your important documentation managed within the eQMS.

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Why are approvals required?

For medical devices, regulations like ISO 13485 require strict control over documents and records. The approval process is critical because it:
  • Ensures Accuracy: Experts review documents for correctness.
  • Demonstrates Control: It shows regulators that you have formal processes for managing your documentation.
  • Maintains Traceability: It creates a record of who approved what and when, which is essential for audits.
  • Prevents Unauthorized Changes: Only approved documents are considered official.
Proper document control and approval are fundamental pillars of a compliant Quality Management System.

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Understanding the document lifecycle

Each time a document is changed and approved, a new revision is created (e.g., Revision 1, Revision 2) and stored in the eQMS. All document versions are managed within the eQMS and have the following statuses:
  • Draft: The document is a draft and has not been reviewed or approved.
  • In Review: The document is currently being reviewed by the approvers.
  • Live: The document has been reviewed and approved by the approvers.
  • Archived: The document has been archived because a new revision has been approved and is now Live. Archived documents are kept for historical records and audit purposes but are no longer the primary version shown in the explorer.

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Approval History

The eQMS keeps track of all revisions, approvers, approval dates, and the revision summaries you provided.
This history is viewable by clicking on the “Approval” button in the top right corner or by scrolling down to the revision history section at the bottom of the document.

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How to approve documents

When a document is ready for review and approval, follow these steps:
  1. Navigate to the Document: Locate and open the document you need approved using the eQMS Document Explorer or jump directly to the document through your Todos.
  2. Initiate Approval: Click the “Approval” button, usually located in the top right corner of the document viewer. This will open the Approval modal.
  3. Assign Approvers: Select the required individuals from the dropdown lists (e.g., “Select Approver #1”, “Select Approver #2”). You might also have the option to invite other users if needed.
  4. Write the Revision Summary: This is a critical step! Provide a clear description of the changes made in this revision.
    • For the very first version: Simply state “Initial release.”
    • For subsequent revisions: Detail exactly what was changed (e.g., “Updated section 4.2 to reflect new testing procedure”, “Corrected typographical errors in Introduction”, “Added Appendix C with validation results”). This creates an essential audit trail visible within the document’s history in the eQMS.
  5. Submit for Approval: Click the “Submit” button. The assigned approvers will be notified via email to review and approve the document.