Pharmaceutical Computer System Validation Checklist

A comprehensive checklist for validating computer systems in pharmaceutical companies to ensure compliance with FDA 21 CFR Part 11, covering all aspects from system development to maintenance.

Pharmaceutical Computer System Validation Checklist
by: audit-now
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About This Checklist

The Pharmaceutical Computer System Validation Checklist is an indispensable tool for ensuring that computerized systems used in drug manufacturing and quality control meet FDA 21 CFR Part 11 requirements. This comprehensive checklist guides pharmaceutical companies through the complex process of validating computer systems, from initial risk assessment to ongoing maintenance. By systematically addressing software development, hardware qualification, and system performance, this checklist helps maintain data integrity, enhance product quality, and streamline regulatory compliance in the increasingly digital pharmaceutical landscape.

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Industry

Pharmaceuticals

Standard

FDA 21 CFR Part 11

Workspaces

Pharmaceutical IT Departments and Manufacturing Facilities

Occupations

IT Validation Specialist
Quality Assurance Engineer
Computer Systems Auditor
Regulatory Compliance Officer
Pharmaceutical Process Engineer

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