21 CFR Part 11

The services we provide for 21 CFR Part 11 include assessments of the implementation in the various systems (operational, production, support, IT, ERP, etc.) including recommendations on how to meet the requirements, validation of the various systems (as defined in the FDA Guidelines for Software Validation and 21 CFR Part 11), implementation of ISO 17799 in the organization and training the organization on the requirements of 21 CFR Part 11.

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