Validation, as regulated by the FDA, ensures that an organization’s product development process and system will meet its intended purpose. This is often the first document examined during a regulatory inspection, and it must show reliable, consistent functionality that is compliant with regulatory and business requirements. Unfortunately, validation plan development and exercises are limited and subject to misinterpretation.
The Cognition Validation Kit is designed to give organizations a starting point for validating Cockpit in their product development processes. It helps reduce the resources required for independent validation of Cockpit. The Validation Kit White Paper outlines its features and functionality, including:
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