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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?

Select compliance status.

To ensure that only authorized personnel can access sensitive electronic records.
2
Is the audit trail feature enabled for electronic records?

Indicate if the audit trail is enabled.

To verify that all changes to electronic records are tracked and can be audited.
3
What data integrity measures are implemented?

Provide details on data integrity measures.

To assess the controls in place ensuring the integrity of electronic records.
4
When was the last validation of the electronic record system performed?

Enter the last validation date.

To ensure that the system is regularly validated as per regulatory requirements.
5
Is the electronic record system validated?

Select validation compliance status.

To confirm that the system meets regulatory standards and is functioning correctly.
6
How often is training on access controls conducted?

Enter the frequency of training in number of times per year.

To evaluate the frequency of training to ensure personnel are aware of access control protocols.
Target: Annually
7
Are there established procedures for backing up electronic records?

Indicate if backup procedures are established.

To ensure that data can be restored in case of loss or corruption, maintaining data integrity.
8
Are tools in place to monitor the integrity of electronic records?

Select the status of data integrity monitoring tools.

To confirm that appropriate tools are utilized to detect and prevent data integrity issues.
9
Document any data integrity issues encountered in the past year.

Provide a detailed account of any data integrity issues.

To evaluate the frequency and nature of data integrity issues within the electronic records system.
10
When was the last audit of data integrity performed?

Enter the date of the last data integrity audit.

To ensure regular audits are conducted to check data integrity compliance.
11
How often are data integrity checks conducted?

Enter the frequency of data integrity checks in terms of times per year.

To assess the diligence in maintaining data integrity through regular checks.
Target: Monthly
12
Is the electronic record system compliant with data integrity standards?

Select compliance status.

To confirm that the system meets established standards for data integrity.
13
Is the electronic records system compliant with FDA regulations?

Select compliance status with FDA regulations.

To ensure adherence to FDA requirements for electronic records.
14
Is regular training provided on compliance with electronic record regulations?

Indicate if training is regularly provided.

To verify that staff is knowledgeable about compliance requirements.
15
Describe the procedures in place to ensure compliance with electronic records regulations.

Provide a detailed description of compliance procedures.

To evaluate the effectiveness of compliance procedures and practices.
16
When was the last review of compliance with electronic records regulations conducted?

Enter the date of the last compliance review.

To ensure that compliance is reviewed regularly.
17
How many compliance violations have been reported in the past year?

Enter the number of compliance violations.

To assess the frequency of compliance violations and address areas for improvement.
Target: 0
18
Has management reviewed compliance with electronic records regulations in the last year?

Select if management review has been conducted.

To ensure that management is actively involved in compliance oversight.
19
Has a risk assessment been conducted for the use of electronic signatures?

Select the status of the risk assessment for electronic signature use.

To ensure that potential risks associated with electronic signature use are identified and mitigated.
20
How many risks have been identified related to electronic records?

Enter the count of identified risks related to electronic records.

To quantify the potential risks associated with electronic records and assess the need for mitigation strategies.
Target: 0
21
Are there established mitigation plans for identified risks?

Indicate if mitigation plans are in place for identified risks.

To ensure that risks are proactively managed through established mitigation strategies.
22
When was the last risk assessment conducted for electronic records?

Enter the date of the last risk assessment.

To verify that regular assessments are being performed to identify and manage risks.
23
Provide a summary of the risk mitigation strategies implemented.

Provide a detailed summary of risk mitigation strategies.

To evaluate the effectiveness of risk mitigation strategies in place for electronic records.
24
Have the risk management policies been reviewed in the past year?

Select if the risk management policies have been reviewed.

To ensure that policies are current and relevant to managing risks effectively.

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