Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist
A comprehensive checklist for ensuring compliance of Electronic Document Management Systems (EDMS) with FDA 21 CFR Part 11 in pharmaceutical companies, covering document control, version management, and regulatory requirements.
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About This Checklist
The Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist is a crucial tool for ensuring that document control systems in pharmaceutical companies adhere to FDA 21 CFR Part 11 regulations. This comprehensive checklist guides organizations through the intricate process of implementing, validating, and maintaining compliant EDMS. By addressing key aspects such as version control, approval workflows, audit trails, and electronic signatures, this checklist helps pharmaceutical companies maintain document integrity, streamline regulatory submissions, and ensure compliance across all stages of drug development and manufacturing documentation.
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