Compliance services for ISO and
FDA regulations since 1994

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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.