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Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist

A comprehensive checklist for ensuring compliance of Electronic Document Management Systems (EDMS) with FDA 21 CFR Part 11 in pharmaceutical companies, covering document control, version management, and regulatory requirements.

Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist

by: audit-now
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About This Checklist

The Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist is a crucial tool for ensuring that document control systems in pharmaceutical companies adhere to FDA 21 CFR Part 11 regulations. This comprehensive checklist guides organizations through the intricate process of implementing, validating, and maintaining compliant EDMS. By addressing key aspects such as version control, approval workflows, audit trails, and electronic signatures, this checklist helps pharmaceutical companies maintain document integrity, streamline regulatory submissions, and ensure compliance across all stages of drug development and manufacturing documentation.

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Industry

Healthcare

Standard

FDA 21 CFR Part 11 - Electronic Records

Workspaces

Pharmaceutical Research
Development
and Manufacturing Facilities

Occupations

Document Control Specialist
Quality Assurance Manager
Regulatory Affairs Coordinator
IT Systems Administrator
Compliance Officer
1
Is the integrity of the electronic documents maintained throughout their lifecycle?
2
Is version control properly implemented in the EDMS?
3
What percentage of the audit trails is accessible and retrievable?
Min: 0
Target: 100
Max: 100
4
Are electronic signatures compliant with FDA 21 CFR Part 11?
5
Is a user authentication mechanism implemented for accessing the EDMS?
6
Describe the access control procedures in place for the EDMS.
7
How many distinct user roles are defined within the EDMS?
Min: 0
Target: 5
Max: 100
8
Is data encryption implemented for documents stored in the EDMS?
9
Is there a training program established for users of the EDMS?
10
How many users have completed the EDMS training program?
Min: 0
Target: 50
Max: 500
11
Are the training materials regularly updated to reflect changes in the EDMS?
12
Provide feedback on the effectiveness of the EDMS training program.
13
Is there a formal procedure for reporting incidents related to the EDMS?
14
How many incidents related to the EDMS were reported in the last year?
Min: 0
Target: 10
Max: 1000
15
Have all non-compliance issues identified in the last audit been resolved?
16
Provide a description of any recent incidents related to the EDMS.
17
Are there formal procedures established for data backup in the EDMS?
18
How frequently are data backups performed (in days)?
Min: 1
Target: 7
Max: 30
19
Is there a process in place to verify the integrity of backups?
20
Describe the disaster recovery plan in place for the EDMS.

FAQs

The checklist covers features such as version control, document lifecycle management, electronic signatures, audit trails, access controls, search capabilities, and integration with other systems.

It includes sections on user authentication, role-based access controls, encryption of sensitive documents, and secure archiving processes.

Yes, the checklist includes specific considerations for cloud-based EDMS, addressing data residency, vendor qualifications, and additional security measures for remote access.

It covers aspects of document creation, review, approval, distribution, periodic review, archiving, and retirement, ensuring a compliant end-to-end document management process.

The checklist covers e-signature implementation, including signature manifestations, signature/record linking, non-repudiation, and compliance with 21 CFR Part 11 requirements for electronic signatures.

Benefits of Pharmaceutical Electronic Document Management System (EDMS) Compliance Checklist

Ensures EDMS compliance with FDA 21 CFR Part 11 requirements

Improves document control and reduces risks of using outdated information

Enhances collaboration and streamlines document approval processes

Facilitates easier regulatory inspections and audits of documentation practices

Supports integration of document management with other quality systems