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GLP Computer System Validation Audit Checklist

A comprehensive checklist for auditing the validation processes of computer systems used in GLP-regulated pharmaceutical research, ensuring compliance with GLP standards and maintaining data integrity.

GLP Computer System Validation Audit Checklist

by: audit-now
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About This Checklist

In the era of digital transformation, ensuring the validation of computer systems used in Good Laboratory Practice (GLP) environments is crucial for maintaining data integrity and regulatory compliance in pharmaceutical research. This GLP Computer System Validation Audit Checklist is designed to help IT specialists, quality assurance personnel, and validation experts evaluate and improve the validation processes for computerized systems used in GLP-regulated activities. By implementing this checklist, pharmaceutical organizations can ensure their computer systems meet regulatory requirements, maintain data reliability, and support the overall integrity of GLP studies.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research IT Department

Occupations

IT Validation Specialist
Quality Assurance Manager
Computer System Validation Lead
GLP Compliance Officer
Laboratory Information Systems Manager
1
Is the computer system currently validated according to GLP standards?
2
Have you reviewed the audit trail for completeness and integrity?
3
How many users have received training on the system?
Min: 1
Target: 5
Max: 100
4
Is the data integrity of the system maintained?
5
Is the software validation protocol documented and accessible?
6
What is the completion status of the current software validation?
7
How many defects have been identified during validation?
Min: 0
Target: 0
Max: 100
8
Is the software compliant with relevant regulatory requirements?
9
Are electronic records accessible to authorized users?
10
Is there a regular backup process in place for electronic records?
11
What is the retention period for electronic records (in years)?
Min: 1
Target: 5
Max: 30
12
How frequently are data integrity checks conducted on electronic records?
13
Is the computerized system validated according to GxP guidelines?
14
Is there a change control process in place for the computerized system?
15
How many user access controls are implemented in the system?
Min: 1
Target: 5
Max: 50
16
Is there an incident management process in place for addressing system issues?
17
How frequently are data reviews conducted to ensure integrity?
18
Is an electronic signature system implemented for data entry?
19
How many data anomalies have been identified in the last audit cycle?
Min: 0
Target: 2
Max: 100
20
Is there a documented process for data backup?

FAQs

The checklist covers areas such as system requirements specification, risk assessment, validation planning, installation qualification, operational qualification, performance qualification, user acceptance testing, change control procedures, and system retirement processes.

Full validation audits should be conducted during initial system implementation and after major upgrades. Periodic re-validation or audit checks should be performed annually or when significant changes occur in the system or its use.

The audit should involve a cross-functional team including IT specialists, quality assurance personnel, validation experts, system owners, and end-users to ensure a comprehensive assessment of the system's compliance and functionality.

By ensuring computer systems are properly validated, this checklist helps maintain the accuracy, reliability, and traceability of electronic data generated and managed in GLP studies, supporting overall data integrity throughout the research lifecycle.

Yes, while maintaining core validation principles, the checklist can be adapted to various types of computer systems used in GLP environments, such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), or analytical instrument software.

Benefits of GLP Computer System Validation Audit Checklist

Ensures compliance with GLP regulations for computerized systems

Enhances data integrity and reliability in research activities

Reduces the risk of data loss, corruption, or unauthorized changes

Facilitates efficient and consistent computer system validation processes

Supports preparedness for regulatory inspections and audits