Document and Record Control SOP
3 000 SEK
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Purpose:
This SOP defines the requirements and controls for the creation, review, approval, distribution, revision, archiving, and retention of quality documents and records within a pharmaceutical quality management system.
Regulatory Alignment:
EU GMP documentation requirements, including principles related to document control, record integrity, and data governance.
Included Files:
• SOP – Document and Record Control
• Document change and revision history template
• Master document register template
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for managing controlled documentation and records.