📝

CFR 21 Part 11 Compliance Checklist

Identify applicable systems for CFR 21 Part 11 compliance

Conduct an inventory and analysis of current software

Establish Validation Plan

Check system for electronic record keeping ability

Ensure system has an audit trail feature

Review procedures for system backups

Determine protection measures for electronic signatures

Approval: Electronic Signature Protection

Evaluate software operational controls

Identify training needs for users

Establish protocols for alterations and modifications

Develop control for record distribution

Implement documented policy for system use

Review procedures for system maintenance

Approval: system maintenance procedures

Execute Periodic Review Strategy

Ensure interoperability among system components

Assess data integrity and confidentiality measures

Approval: Data Integrity and Confidentiality Measures

Close project after ensuring compliance

Identify applicable systems for CFR 21 Part 11 compliance

This task involves identifying the systems within the organization that need to comply with CFR 21 Part 11 regulations. The goal is to ensure that all relevant systems are included in the compliance process. Consider the impact on the overall process and the desired results. Are there any challenges in identifying the systems? What resources or tools can be used to assist in this task?

Name of the system

System type

1

ERP
2

CRM
3

Document Management
4

Lab Management
5

Quality Management

Conduct an inventory and analysis of current software

This task involves conducting an inventory and analysis of the current software used within the organization. The goal is to determine if the software can meet the requirements for CFR 21 Part 11 compliance. Consider the impact on the overall process and the desired results. What information or data needs to be collected for the analysis? Are there any challenges in conducting the inventory? What resources or tools can be used for this task?

Current software name

Description of the software

Inventory checklist

1

Version number
2

Vendor information
3

Functionality

Establish Validation Plan

This task involves establishing a validation plan for the systems identified for CFR 21 Part 11 compliance. The goal is to outline the steps and activities required to validate the systems. Consider the impact on the overall process and the desired results. How will the validation plan be developed? What information or data needs to be included in the plan? Are there any challenges in establishing the plan? What resources or tools can be used for this task?

Validation plan name

Validation plan activities