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FDA 21 CFR Part 11 Compliance Checklist

A comprehensive checklist to ensure compliance with FDA 21 CFR Part 11 regulations for electronic records and electronic signatures in pharmaceutical companies.

FDA 21 CFR Part 11 Compliance Checklist

by: audit-now
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About This Checklist

The FDA 21 CFR Part 11 Compliance Checklist is an essential tool for pharmaceutical companies to ensure their electronic records and electronic signatures meet regulatory requirements. This comprehensive checklist helps organizations navigate the complex landscape of data integrity, system validation, and documentation in the digital age. By addressing key aspects of electronic record-keeping and signature processes, this checklist enables companies to maintain compliance, reduce risks, and streamline their quality management systems.

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Industry

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Quality Assurance Manager
IT Professional
Regulatory Affairs Specialist
Compliance Officer
Validation Engineer
1
Are access controls in place for electronic records?
2
Is the audit trail feature enabled for electronic records?
3
What data integrity measures are implemented?
4
When was the last validation of the electronic record system performed?
5
Is the electronic record system validated?
6
How often is training on access controls conducted?
Target: Annually
7
Are there established procedures for backing up electronic records?
8
Are tools in place to monitor the integrity of electronic records?
9
Document any data integrity issues encountered in the past year.
10
When was the last audit of data integrity performed?
11
How often are data integrity checks conducted?
Target: Monthly
12
Is the electronic record system compliant with data integrity standards?
13
Is the electronic records system compliant with FDA regulations?
14
Is regular training provided on compliance with electronic record regulations?
15
Describe the procedures in place to ensure compliance with electronic records regulations.
16
When was the last review of compliance with electronic records regulations conducted?
17
How many compliance violations have been reported in the past year?
Target: 0
18
Has management reviewed compliance with electronic records regulations in the last year?
19
Has a risk assessment been conducted for the use of electronic signatures?
20
How many risks have been identified related to electronic records?
Target: 0
21
Are there established mitigation plans for identified risks?
22
When was the last risk assessment conducted for electronic records?
23
Provide a summary of the risk mitigation strategies implemented.
24
Have the risk management policies been reviewed in the past year?

FAQs

The checklist covers areas such as system validation, audit trails, electronic signatures, access controls, documentation, and data retention policies.

The primary purpose is to ensure that pharmaceutical companies comply with FDA regulations regarding electronic records and electronic signatures, maintaining data integrity and security in their digital systems.

This checklist should be used by quality assurance managers, IT professionals, regulatory affairs specialists, and compliance officers in pharmaceutical companies.

The checklist should be used regularly, typically on a quarterly or semi-annual basis, and whenever significant changes are made to electronic systems or processes.

By regularly using this checklist, companies can maintain comprehensive documentation of their compliance efforts, making it easier to demonstrate adherence to FDA regulations during inspections.

Benefits of FDA 21 CFR Part 11 Compliance Checklist

Ensures compliance with FDA 21 CFR Part 11 regulations

Improves data integrity and security in electronic systems

Facilitates easier audits and inspections

Reduces the risk of regulatory non-compliance and associated penalties

Enhances overall quality management in pharmaceutical operations