Document control system establishes procedures managing pharmaceutical documentation preventing unauthorised modifications and ensuring traceability. Version control tracks document evolution. Approval workflows enforce authorisation before implementation. Change history documents all modifications. Access controls limit document viewing to authorised personnel.
Regulatory submissions reference approved documents establishing compliance. Electronic systems provide audit trails documenting access. Archive systems maintain historical documents supporting regulatory inquiries. Quality management system incorporation establishes document priorities. Regulatory inspections verify control system compliance.
General Biopharmaceutical Concepts
Document Control System
A document control system manages the creation, review, approval, revision and distribution of regulated documents throughout their lifecycle.
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