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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?

Select the status of document integrity.

To ensure that the documents are not altered or tampered with during their lifecycle.
2
Is version control properly implemented in the EDMS?

Indicate whether version control is implemented.

To verify that all document versions are tracked and managed appropriately.
3
What percentage of the audit trails is accessible and retrievable?

Enter the percentage of accessible audit trails.

To measure the accessibility of audit trails for compliance verification.
Min: 0
Target: 100
Max: 100
4
Are electronic signatures compliant with FDA 21 CFR Part 11?

Select compliance status of electronic signatures.

To ensure that all electronic signatures meet regulatory requirements.

5
Is a user authentication mechanism implemented for accessing the EDMS?

Indicate if user authentication exists.

To confirm that only authorized personnel can access sensitive documents.
6
Describe the access control procedures in place for the EDMS.

Provide detailed information about access control procedures.

To evaluate the effectiveness of access controls and user permissions.
7
How many distinct user roles are defined within the EDMS?

Enter the total number of user roles.

To assess the granularity of user access levels and permissions.
Min: 0
Target: 5
Max: 100
8
Is data encryption implemented for documents stored in the EDMS?

Select the encryption status.

To ensure that sensitive data is protected through encryption methods.

9
Is there a training program established for users of the EDMS?

Indicate if a training program is in place.

To ensure that all users are adequately trained on the system's functionalities and compliance requirements.
10
How many users have completed the EDMS training program?

Enter the number of trained users.

To gauge the level of user engagement and training completion.
Min: 0
Target: 50
Max: 500
11
Are the training materials regularly updated to reflect changes in the EDMS?

Select the status of training material updates.

To ensure that users have access to the most current information and procedures.
12
Provide feedback on the effectiveness of the EDMS training program.

Share your feedback regarding the training program.

To gather insights on user satisfaction and areas for improvement in training.

13
Is there a formal procedure for reporting incidents related to the EDMS?

Indicate if an incident reporting procedure exists.

To ensure that all incidents are reported and addressed in a timely manner.
14
How many incidents related to the EDMS were reported in the last year?

Enter the number of reported incidents.

To assess the frequency of incidents and the effectiveness of the reporting procedure.
Min: 0
Target: 10
Max: 1000
15
Have all non-compliance issues identified in the last audit been resolved?

Select the resolution status of non-compliance issues.

To ensure that any identified non-compliance issues are addressed promptly.
16
Provide a description of any recent incidents related to the EDMS.

Detail any recent incidents that occurred.

To document and analyze recent incidents for future prevention.

17
Are there formal procedures established for data backup in the EDMS?

Indicate if data backup procedures are in place.

To ensure that data is regularly backed up to prevent loss.
18
How frequently are data backups performed (in days)?

Enter the frequency of data backups in days.

To assess the regularity of data backups and minimize data loss risk.
Min: 1
Target: 7
Max: 30
19
Is there a process in place to verify the integrity of backups?

Select the status of backup verification.

To ensure that backups are reliable and can be restored successfully.
20
Describe the disaster recovery plan in place for the EDMS.

Provide details about the disaster recovery plan.

To evaluate the preparedness for data recovery in case of a disaster.

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

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