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Pharmaceutical Data Integrity and Computer System Validation Audit Checklist

A comprehensive checklist for auditing data integrity practices and computer system validation in pharmaceutical operations to ensure regulatory compliance and data reliability.

Pharmaceutical Data Integrity and Computer System Validation Audit Checklist
by: audit-now
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About This Checklist

Data integrity and validated computer systems are fundamental to ensuring the reliability and trustworthiness of pharmaceutical operations. This Pharmaceutical Data Integrity and Computer System Validation Audit Checklist is an essential tool for evaluating the robustness of data management practices and the compliance of computerized systems used in pharmaceutical processes. By systematically assessing data governance, system validation, access controls, audit trails, and data lifecycle management, this checklist helps maintain regulatory compliance and data reliability across all computerized systems. Regular implementation of this comprehensive audit process can significantly reduce risks associated with data manipulation, enhance the quality of regulatory submissions, and support overall confidence in pharmaceutical research and manufacturing data.

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Industry

Pharmaceuticals

Standard

21 CFR Part 11, EU GMP Annex 11, GAMP 5

Workspaces

Research laboratories

Occupations

IT Quality Assurance Specialist
Computer System Validation Expert
Data Integrity Officer
Quality Control Manager
Regulatory Compliance Specialist

Data Integrity and System Validation Audit

(0 / 4)

1
How often is training on data integrity principles conducted?

Enter the frequency in months.

To ensure personnel are adequately trained on data integrity practices.
Min: 1
Target: Quarterly
Max: 12
2
Describe the data lifecycle management process in place for the system.

Provide a detailed description.

To evaluate the effectiveness of data management practices throughout its lifecycle.
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3
Is the audit trail feature enabled on the system?

Indicate if the feature is enabled.

To maintain a record of all changes made to data and ensure traceability.
4
Is access to the system controlled and restricted to authorized personnel only?

Select compliance status.

To ensure that only authorized individuals can access sensitive data and systems.
5
Provide a description of the change control process implemented for the system.

Describe the change control process in detail.

To evaluate how changes to the system are managed to maintain compliance and data integrity.
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6
What was the error rate observed during the last validation process?

Enter the error rate as a percentage.

To assess the effectiveness of the validation process and identify areas for improvement.
Min: 0
Target: 0%
Max: 100
7
What is the date of the last validation performed on the system?

Enter the last validation date.

To track the recency of validation efforts and compliance with regulations.
8
Is the validation documentation complete and up to date?

Select validation documentation status.

To ensure that all necessary validation documents are in place and reflect the current system state.
9
Describe the training provided on data governance and integrity principles.

Provide a detailed description of the training.

To evaluate the adequacy of training provided to staff regarding data governance.
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10
What is the date of the next scheduled data integrity audit?

Enter the next scheduled audit date.

To ensure that upcoming audits are planned and documented for compliance tracking.
11
Have regular data integrity audits been conducted as per the governance policy?

Indicate if audits have been conducted.

To ensure that data integrity is routinely assessed and maintained.
12
Is there a documented data governance policy available?

Select the availability status of the data governance policy.

To ensure that the organization has a formal policy governing data integrity and management.
13
Describe the corrective actions taken to address any identified issues.

Provide a detailed description of corrective actions.

To evaluate the effectiveness of corrective actions in improving compliance and system integrity.
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14
When was the last compliance review conducted on the system?

Enter the date of the last compliance review.

To ensure that compliance reviews are conducted regularly and documented.
15
How many non-conformities were identified during the last audit?

Enter the number of non-conformities.

To assess the effectiveness of the compliance program and identify areas for improvement.
Min: 0
Target: 0
Max: 100
16
Is the system compliant with applicable regulatory requirements?

Select the regulatory compliance status.

To verify that the system adheres to relevant regulations such as 21 CFR Part 11.
17
Describe the procedures in place for responding to data integrity incidents.

Provide a detailed description of incident response procedures.

To evaluate the organization's preparedness in addressing data integrity breaches.
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18
What is the average turnaround time for data corrections?

Enter the average turnaround time in hours.

To assess the efficiency of the process for addressing and correcting data issues.
Min: 0
Target: 1 day
Max: 72
19
Are regular data audits conducted to verify data integrity?

Indicate if regular data audits are conducted.

To ensure that data integrity is routinely assessed and maintained.
20
Does the data management process adhere to ALCOA+ principles?

Select adherence status.

To ensure that data integrity is maintained according to established ALCOA+ guidelines.

FAQs

These audits should be conducted at least annually for critical systems. Additionally, audits should be performed after significant system changes, upgrades, or when new systems are implemented.

This checklist covers data governance policies, system validation documentation, access control measures, audit trail reviews, data backup and recovery processes, change management procedures, and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

These audits are typically conducted by IT quality assurance specialists, computer system validation experts, or qualified auditors with expertise in both pharmaceutical regulations and information technology.

The checklist ensures that all aspects of data management and computerized systems meet regulatory requirements, including FDA's 21 CFR Part 11 and EMA's guidance on data integrity, which are crucial for maintaining the validity and reliability of pharmaceutical data.

If data integrity issues are identified, actions should include immediate assessment of the impact on product quality and patient safety, investigation of the root cause, implementation of corrective measures, potential data remediation, system revalidation if necessary, and enhanced monitoring and training. All actions must be meticulously documented and reported to management.

Benefits

Ensures compliance with data integrity regulations and GAMP 5 guidelines

Reduces risks of data manipulation, loss, or unauthorized access

Improves reliability and trustworthiness of pharmaceutical data

Enhances the quality and acceptability of regulatory submissions

Facilitates early detection of potential data integrity issues