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.

Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist
by: audit-now
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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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Industry

Pharmaceuticals

Standard

FDA 21 CFR Part 11

Workspaces

Pharmaceutical Research
Development
and Manufacturing Facilities

Occupations

Document Control Specialist
Quality Assurance Manager
Regulatory Affairs Coordinator
IT Systems Administrator
Compliance Officer

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