Part 11 Compliance Procedures

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Part 11 Compliance Procedures

The policies, procedures and templates are priced at a fraction of the cost to develop such documents. Customization services are also available.

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Procedure Title	Purpose	Comments
Assessing and Achieving Compliance with 21CFR Part 11	To define the process for determining if Part 11 applies, assessing compliance with the regulation, and creating a remediation plan.	None.
Determining 21 CFR Part 11 Compliance for Existing Systems	To provide checklists to be used to 1) determine if a system needs to comply with Part 11; 2) determine compliance or non conformance of a system with each of the Part 11 regulations.	None.
Management of Electronic Records	The purpose of this procedure is to define the process for the creation, management and retention of electronic quality records.	None.
Creating an Electronic Record	The purpose of this work instruction is to define acceptable standards for recording data and/or changing electronic quality records.	None.