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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
4.3

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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

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

IT Validation Specialist
Quality Assurance Engineer
Computer Systems Auditor
Regulatory Compliance Officer
Pharmaceutical Process Engineer
1
Is the computer system properly qualified as per GxP compliance requirements?
2
What is the version number of the validation protocol used?
Min: 1
Target: 1.0
Max: 5
3
What is the current compliance maturity level of the computerized system?
4
Have any data integrity issues been identified in the system?
5
Is the software validated according to FDA 21 CFR Part 11 requirements?
6
Provide a summary of the validation process conducted for the software.
7
What is the risk assessment score assigned to the software?
Min: 1
Target: 2
Max: 5
8
When was the last validation conducted for the software?
9
Is there an access control policy implemented for the computerized system?
10
Is the audit trail functionality of the system active and properly configured?
11
Are training records for users of the computerized system up to date?
12
When was the last compliance review of the computerized system conducted?
13
Has the software change been approved by the relevant stakeholders?
14
What is the identification number of the change request?
Min: 1
Target: 12345
Max: 99999
15
Provide a detailed description of the change being implemented.
16
When is the change scheduled to be implemented?
17
Is sensitive data encrypted both at rest and in transit?
18
Is there an incident response plan in place for data breaches?
19
When was the last review of data access permissions conducted?
20
How many security incidents have been reported in the last year?
Min: 0
Target: 0
Max: 100

FAQs

The checklist covers all phases including planning, specification, design, development, testing, implementation, and maintenance of computerized systems.

It includes specific sections for validating cloud-based and SaaS applications, focusing on data security, access controls, and vendor qualifications.

The checklist requires documentation such as validation plans, user requirements, functional specifications, risk assessments, test protocols, and validation reports.

The checklist recommends periodic revalidation based on risk assessment, typically annually or after significant system changes or upgrades.

Yes, the checklist includes sections for retrospective validation of legacy systems, ensuring they meet current regulatory requirements.

Benefits of Pharmaceutical Computer System Validation Checklist

Ensures compliance with FDA 21 CFR Part 11 for computerized systems

Reduces risks associated with computer system failures or data integrity issues

Improves efficiency in the validation process

Facilitates consistent and standardized approach to system validation

Supports easier regulatory inspections and audits of computerized systems