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Pharmaceutical Data Integrity Audit Checklist

A comprehensive checklist for auditing data integrity practices in pharmaceutical companies to ensure compliance with FDA 21 CFR Part 11 and maintain the highest standards of data quality and reliability.

Pharmaceutical Data Integrity Audit Checklist

by: audit-now
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About This Checklist

The Pharmaceutical Data Integrity Audit Checklist is a crucial tool for ensuring the accuracy, consistency, and reliability of data throughout the drug development and manufacturing process. In an industry where data integrity is paramount for patient safety and regulatory compliance, this checklist serves as a comprehensive guide to assess and maintain the quality of electronic records. By addressing key aspects of data management, system controls, and documentation practices, this checklist helps pharmaceutical companies uphold the highest standards of data integrity in accordance with FDA 21 CFR Part 11 regulations.

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Industry

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Quality Assurance Specialist
Data Integrity Auditor
Compliance Manager
IT Systems Validator
Pharmaceutical Researcher
1
Is the electronic record system compliant with FDA 21 CFR Part 11?
2
Please describe the process for reviewing audit trails.
3
How often is the system validated?
Min: 1
Target: 12
Max: 24
4
What is the current level of data governance implemented?
5
Is access to electronic records restricted to authorized personnel only?
6
Describe the procedure for reporting data integrity incidents.
7
How often is staff trained on data integrity practices?
Min: 1
Target: 6
Max: 12
8
Is the system validated as per the required standards?
9
Are electronic records retained for the required duration as per FDA regulations?
10
What challenges are faced in maintaining data integrity?
11
When was the last audit of the electronic record system conducted?
12
How often are user access rights reviewed?
Min: 1
Target: 3
Max: 12
13
Is data encryption implemented for electronic records?
14
Describe the response plan for a data breach.
15
How often is incident response training conducted for staff?
Min: 1
Target: 12
Max: 24
16
When was the last review of data encryption practices conducted?
17
Is there a compliant data backup process in place for electronic records?
18
What metrics are used to measure data integrity?
19
How often are audits conducted to assess data integrity?
Min: 1
Target: 6
Max: 12
20
Describe the actions taken to improve data integrity.

FAQs

The checklist covers areas such as data acquisition, processing, retention, backup, archiving, system access controls, audit trails, and data review processes.

It ensures that data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete, plus Consistent, Enduring, and Available (ALCOA+) by providing specific checkpoints for each principle.

The audit should involve a cross-functional team including quality assurance personnel, IT specialists, data managers, and subject matter experts from relevant departments.

Data integrity audits should be performed at least annually, or more frequently if there are significant changes in systems, processes, or regulatory requirements.

Yes, the checklist can be tailored to specific operations such as research and development, clinical trials, manufacturing, or quality control, while maintaining core data integrity principles.

Benefits of Pharmaceutical Data Integrity Audit Checklist

Ensures compliance with data integrity requirements in FDA 21 CFR Part 11

Identifies potential vulnerabilities in data management processes

Enhances the reliability and traceability of pharmaceutical data

Supports continuous improvement in data governance practices

Facilitates smoother regulatory inspections and audits