Taking the Pain Out of Document Change Control

Imagine, the health authority is on-site and the inspector asks for your document change control procedure. It’s a robust process, but does your organization follow it? Do you have the necessary records to prove it? FDA warning letters show that companies are frequently cited for deficiencies in their documentation change control procedures.

Managing change to your company’s quality system documentation can be daunting. Deviations, out of specification test results, audit findings, complaints and many other factors create a constant state of flux. Controlling and chronicling those changes is critical for product quality and compliance with health authority regulations. The penalty for not following through can lead to fines, product recalls, or facility shutdowns.

The change control feature included in the latest release of Veeva Vault QualityDocs, enables companies to fully control quality system documentation changes, reducing the risk of non-compliance.

A typical change control process involves identifying everything that has been altered, tracking those actions, and making sure the changes are executed as documented. Although common business events, such as replacing equipment in a lab, implementing a computer system, or commissioning a new facility, are different actions, they all require modifications to documents. Adopting a formal procedure to propose, review, and make changes to documents is critical to ensuring the success of any change control process.

The change control feature in Vault QualityDocs enforces an approval process for revising or withdrawing documents. Configurable forms capture information including summary of the change, the reason for the change, and originating and affected sites and departments. Proposed changes are shown as redline markups and users can attach supporting documentation.

When requesting a modification, the change request form is pre-populated with information from the affected document and contains a link back to the original document. A banner at the top of the original document notes that it’s in the change control process. Once a change has been approved, the system automatically takes the appropriate action either creating a new draft version or withdrawing the document. The change control feature can be enabled for only specific documents or document types.

Vault QualityDocs includes several other important capabilities such as automatic management of minor and major versions, version comparison capabilities, and version-specific access. As a secure cloud application that is available anytime, anywhere, Vault QualityDocs empower companies to manage documentation changes in real-time.

Bob Kenney is Vault QualityDocs product specialist at Veeva.