Document Control

Document Control. The Manufacturer shall establish and maintain a document control system that governs the creation, review, approval, distribution, revision, and retirement of all quality-related documents, including but not limited to standard operating procedures (SOPs), work instructions, specifications, batch records, validation protocols, and quality agreements. All documents shall be uniquely identified with a document number, revision level, and effective date. Documents shall not be implemented until formally approved by authorized personnel through the document management system. Obsolete documents shall be promptly removed from all points of use and archived in accordance with applicable retention requirements. The Manufacturer shall maintain a master document list that identifies the current revision status of all controlled documents. Any changes to controlled documents shall be processed through the change control system and shall require the same level of review and approval as the original document.