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Pharmaceutical Computerized System Validation Audit Checklist

A comprehensive checklist for auditing pharmaceutical computerized system validation processes to ensure compliance with regulatory standards, maintain data integrity, and support reliable electronic record-keeping in pharmaceutical operations.

Pharmaceutical Computerized System Validation Audit Checklist

by: audit-now
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About This Checklist

The Pharmaceutical Computerized System Validation Audit Checklist is a critical tool for ensuring the reliability, integrity, and compliance of computerized systems used in pharmaceutical operations. This comprehensive checklist addresses key aspects of computer system validation, from requirements specification to system retirement, helping to maintain data integrity and regulatory compliance. By implementing this checklist, pharmaceutical companies can enhance their computerized system validation practices, meet regulatory expectations, and ensure the consistent quality and reliability of their electronic records and data management processes.

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Industry

Healthcare

Standard

Electronic Records Standards

Workspaces

Research Facilities

Occupations

IT Quality Assurance Specialist
Computer System Validation Engineer
IT Compliance Manager
Quality Systems Analyst
Regulatory Affairs Specialist
1
Is the computerized system compliant with 21 CFR Part 11?
2
Is the validation documentation complete and up to date?
3
What is the data integrity assessment score?
Min: 0
Target: 80
Max: 100
4
Is the system lifecycle management compliant with EU GMP Annex 11?
5
Is the user access control compliant with regulatory requirements?
6
Is the audit trail feature enabled in the system?
7
What is the average incident response time in hours?
Min: 0
Target: 4
Max: 24
8
Describe the security measures implemented for the computerized system.

FAQs

The checklist covers key phases such as system requirements specification, design qualification, installation qualification, operational qualification, performance qualification, user acceptance testing, change control, and system retirement.

Computerized system validation audits should be conducted periodically, typically annually for critical systems, after major upgrades, and prior to regulatory inspections.

Computerized system validation audits are typically conducted by IT quality assurance personnel, validation specialists, or external consultants with expertise in pharmaceutical computer system validation and regulatory requirements.

Non-compliance issues can lead to data integrity concerns, regulatory findings, product quality impacts, delays in regulatory submissions, and potential legal or financial consequences if data reliability is compromised.

By ensuring robust validation of computerized systems, this checklist helps maintain data integrity, enhances the reliability of electronic records, and supports compliant and efficient pharmaceutical operations across various functional areas.

Benefits of Pharmaceutical Computerized System Validation Audit Checklist

Ensures compliance with 21 CFR Part 11 and EU GMP Annex 11 for computerized systems

Improves data integrity and reliability across pharmaceutical operations

Enhances traceability and auditability of computerized system lifecycles

Reduces the risk of data-related compliance issues during regulatory inspections

Supports efficient and consistent validation practices across different systems