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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FAQs
The checklist covers features such as version control, document lifecycle management, electronic signatures, audit trails, access controls, search capabilities, and integration with other systems.
It includes sections on user authentication, role-based access controls, encryption of sensitive documents, and secure archiving processes.
Yes, the checklist includes specific considerations for cloud-based EDMS, addressing data residency, vendor qualifications, and additional security measures for remote access.
It covers aspects of document creation, review, approval, distribution, periodic review, archiving, and retirement, ensuring a compliant end-to-end document management process.
The checklist covers e-signature implementation, including signature manifestations, signature/record linking, non-repudiation, and compliance with 21 CFR Part 11 requirements for electronic signatures.
Benefits of Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist
Ensures EDMS compliance with FDA 21 CFR Part 11 requirements
Improves document control and reduces risks of using outdated information
Enhances collaboration and streamlines document approval processes
Facilitates easier regulatory inspections and audits of documentation practices
Supports integration of document management with other quality systems