PHARMACEUTICAL DOCUMENT CONTROL CHECKLIST Created by ChecklistGuro (https://checklistguro.com) --- DOCUMENT CREATION & APPROVAL --- [ ] Document Title [ ] Document Purpose/Scope [ ] Document Type (SOP, Form, Report, etc.) (SOP, Form, Report, Record, Other) [ ] Document Classification (Confidential, Public, etc.) (Public, Confidential, Restricted) [ ] Date of Creation [ ] Document Version Number [ ] Author Signature [ ] Reviewer Signature --- DOCUMENT REVIEW & REVISION --- [ ] Review Date [ ] Reviewer Role (Subject Matter Expert, Quality Assurance, Regulatory Affairs) [ ] Review Comments/Observations [ ] Revision Number (if applicable) [ ] Review Result (Approved, Requires Revision, Rejected) [ ] Reviewer Signature [ ] Approval Date (if approved) --- DOCUMENT DISTRIBUTION & ACCESS --- [ ] Distribution Method (Electronic (Controlled), Printed (Controlled)) [ ] Recipients (Document Distribution List) (QA Department, Manufacturing Team, Validation Team, Regulatory Affairs) [ ] Distribution Notes/Comments [ ] Date of Distribution [ ] Distribution Acknowledgement --- DOCUMENT STORAGE & RETENTION --- [ ] Total Number of Documents Stored [ ] Last Storage System Review Date [ ] Physical Storage Location (if applicable) [ ] Description of Storage Conditions (e.g., temperature, humidity) [ ] Retention Period (Years) [ ] Document Destruction Start Date (if applicable) [ ] Storage Media Type (Electronic/Physical) (Electronic, Physical) --- DOCUMENT RETRIEVAL & AVAILABILITY --- [ ] Date of Last Document Retrieval [ ] Document Retrieval Purpose/Reason [ ] Retrieval Method (e.g., Electronic, Paper) (Electronic, Paper) [ ] Number of Documents Retrieved [ ] Location of Document Retrieval (e.g., Server, Archive) [ ] Time of Retrieval --- OBSOLETE DOCUMENT CONTROL --- [ ] Date of Document Identification as Obsolete [ ] Reason for Document Obsolescence (Superseded by newer version, Process Change, Regulatory Change, Other) [ ] Description of the reason for obsolescence [ ] Upload Document for Review (Optional) [ ] Document Status Post-Obsolescence (Archived, Removed from Active Distribution, Scheduled for Destruction) [ ] Reviewer Signature [ ] Document ID --- CHANGE MANAGEMENT (DOCUMENTS) --- [ ] Change Request Date [ ] Reason for Change [ ] Detailed Description of Change [ ] Affected Document(s) (SOP, Manufacturing Record, Validation Protocol, Other (Specify)) [ ] Document Revision Number (Before Change) [ ] Document Revision Number (After Change) [ ] Supporting Documentation [ ] Preparer Signature [ ] Reviewer Signature --- DOCUMENT MASTER RECORD (DMR) REVIEW --- [ ] DMR Review Date [ ] DMR Version Number [ ] Review Status (Approved, Rejected, Requires Revision) [ ] Review Comments/Observations [ ] Reviewer Signature [ ] Deviation Identified? (Yes, No) [ ] Supporting Documentation (if applicable) --- END OF TEMPLATE --- Transform this text into a digital, automated, and trackable mobile app! Visit: https://checklistguro.com/templates/pharmaceutical/pharmaceutical-document-control-checklist (Click "Install Template" to launch your digital inspection tool immediately)