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21 CFR Part 11 Compliance Audit Checklist

A comprehensive checklist for auditing compliance with 21 CFR Part 11 regulations in pharmaceutical electronic systems

21 CFR Part 11 Compliance Audit Checklist

by: audit-now
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About This Checklist

The 21 CFR Part 11 Compliance Audit Checklist is an essential tool for pharmaceutical companies to ensure adherence to FDA regulations regarding electronic records and electronic signatures. This comprehensive checklist addresses key aspects of data integrity, system validation, and documentation control, helping organizations maintain compliance and mitigate risks associated with electronic systems in regulated environments. By systematically evaluating your processes against 21 CFR Part 11 requirements, you can identify gaps, implement necessary controls, and demonstrate your commitment to data reliability and regulatory compliance.

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Industry

Healthcare

Standard

21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical manufacturing facilities
Research Facilities
Research Facilities

Occupations

Quality Assurance Specialist
Regulatory Affairs Manager
IT Compliance Officer
Validation Engineer
Clinical Data Manager
1
Is the electronic record system validated as per 21 CFR Part 11 requirements?
2
Is the audit trail feature enabled for all electronic records?
3
What is the record retention policy for electronic records?
4
How many electronic signatures are currently active in the system?
Min: 0
Max: 1000
5
Has a data integrity check been conducted in the last 12 months?
6
When was the last system update performed?
7
Is the electronic signature authentication method compliant with 21 CFR Part 11?
8
Have all users received training on the proper use of electronic signatures?
9
What documentation is in place for the electronic signature policy?
10
How many users have access to use electronic signatures?
Min: 0
Max: 500
11
How often are electronic signatures audited for compliance?
12
When was the last audit of electronic signatures performed?
13
How often is the data integrity of electronic records assessed?
14
Are backup procedures for electronic records documented and implemented?
15
What is the process for reporting data integrity incidents?
16
How many data integrity issues have been resolved in the past year?
Min: 0
Max: 100
17
When was the last training on data integrity for staff conducted?
18
What were the results of the last data integrity review?
19
Are access control mechanisms in place to restrict unauthorized access to electronic records?
20
Are electronic records encrypted to protect data integrity and confidentiality?
21
What is the incident response plan for data breaches related to electronic records?
22
How many unauthorized access attempts to electronic records have been recorded in the last year?
Min: 0
Max: 1000
23
When was the last security audit conducted on electronic records?
24
Have all employees received training on security measures for electronic records?
25
Are change control procedures documented and followed for electronic records?
26
Is an impact assessment conducted prior to implementing changes to electronic records?
27
What documentation is required for a change request related to electronic records?
28
How many changes to electronic records have been implemented in the past year?
Min: 0
Max: 200
29
When was the last review of the change management process conducted?
30
Have all relevant staff received training on change management procedures?

FAQs

The primary purpose is to assess and ensure compliance with FDA regulations regarding electronic records and electronic signatures in pharmaceutical companies.

The frequency can vary, but it's generally recommended to conduct these audits at least annually or whenever significant changes are made to electronic systems.

Key personnel should include IT managers, quality assurance professionals, regulatory affairs specialists, and system owners or administrators.

Key areas include system validation, audit trail reviews, electronic signature controls, system access and security measures, and data backup and recovery procedures.

The checklist helps identify and address compliance gaps proactively, ensuring that systems and processes are in line with 21 CFR Part 11 requirements before an FDA inspection occurs.

Benefits of 21 CFR Part 11 Compliance Audit Checklist

Ensures comprehensive coverage of 21 CFR Part 11 requirements

Facilitates consistent and thorough audits across different electronic systems

Helps identify compliance gaps and areas for improvement

Supports documentation of audit findings and corrective actions

Demonstrates due diligence to regulatory authorities