Overview
Document Release Approval is the controlled decision process to make a GxP document available for use in operations, quality, or regulatory activities. It confirms that assigned reviewers and approvers have checked content for accuracy, completeness, and compliance with relevant procedures, regulations, and standards.
This concept matters because it prevents use of unapproved or outdated controlled documents in manufacturing, laboratory, and quality processes. It supports data integrity, regulatory compliance, and clear responsibility by recording who approved the document, when they approved it, and under which version and effective date it can be used.
Additional Resources
CQ Resources
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