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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

Pharmaceuticals

Standard

Good Laboratory Practice (GLP)

Workspaces

Pharmaceutical Research IT Department

Occupations

IT Validation Specialist
Quality Assurance Manager
Computer System Validation Lead
GLP Compliance Officer
Laboratory Information Systems Manager

Computer System Validation Audit

(0 / 4)

1
Is the data integrity of the system maintained?

Select the current status of data integrity.

To ensure data reliability and accuracy as per regulatory requirements.
2
How many users have received training on the system?

Enter the number of users trained on the system.

To ensure that all users are adequately trained to operate the system.
Min: 1
Target: 5
Max: 100
3
Have you reviewed the audit trail for completeness and integrity?

Provide details on the audit trail review.

To verify that all actions taken on the system are recorded and traceable.
4
Is the computer system currently validated according to GLP standards?

Select the current validation status of the system.

To ensure that the system complies with regulatory requirements.
5
Is the software compliant with relevant regulatory requirements?

Select the current regulatory compliance status of the software.

To confirm that the software meets the necessary regulatory standards.
6
How many defects have been identified during validation?

Enter the number of defects found during the validation process.

To assess the quality of the software and ensure all defects are documented.
Min: 0
Target: 0
Max: 100
7
What is the completion status of the current software validation?

Select the current completion status of the software validation.

To track the progress of software validation and identify any outstanding tasks.
8
Is the software validation protocol documented and accessible?

Provide details on the availability of the validation protocol.

To ensure that all validation activities are guided by an approved protocol.
9
How frequently are data integrity checks conducted on electronic records?

Select the frequency for conducting data integrity checks.

To ensure the accuracy and reliability of the stored data.
10
What is the retention period for electronic records (in years)?

Enter the number of years for which electronic records are retained.

To comply with regulatory requirements regarding data retention.
Min: 1
Target: 5
Max: 30
11
Is there a regular backup process in place for electronic records?

Indicate whether a backup process is in place.

To ensure data integrity and recovery in case of loss.
12
Are electronic records accessible to authorized users?

Select the current accessibility status of electronic records.

To ensure that access controls are in place to protect sensitive data.
13
Is there an incident management process in place for addressing system issues?

Select the current status of the incident management process.

To ensure that any incidents affecting the system are tracked and resolved efficiently.
14
How many user access controls are implemented in the system?

Enter the number of user access controls implemented.

To ensure that user access is appropriately restricted to maintain system integrity.
Min: 1
Target: 5
Max: 50
15
Is there a change control process in place for the computerized system?

Indicate whether a change control process exists.

To ensure that any changes to the system are properly managed and documented.
16
Is the computerized system validated according to GxP guidelines?

Select the validation status of the computerized system.

To ensure compliance with Good Practice standards for computerized systems.
17
Is there a documented process for data backup?

Select the current status of the data backup process.

To ensure data can be restored in case of loss and that processes are properly outlined.
18
How many data anomalies have been identified in the last audit cycle?

Enter the number of data anomalies found during the last audit.

To assess the effectiveness of data integrity measures and identify areas for improvement.
Min: 0
Target: 2
Max: 100
19
Is an electronic signature system implemented for data entry?

Indicate whether an electronic signature system is in place.

To comply with regulatory requirements for data integrity and authentication.
20
How frequently are data reviews conducted to ensure integrity?

Select the frequency for conducting data reviews.

To ensure regular checks are in place to maintain the accuracy of data.

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

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