The Cockpit Platform

Validation Overview

Staying Compliant with the Cockpit® Validation Kit


ValidationOverview_LPImageBecause of FDA guidance and internal business requirements, many medical device, pharmaceutical, and combination product teams struggle with the process for validating software solutions they utilize in their product development processes. Whenever the solution is implemented, upgraded, or modified, organizations should be ensuring that it is validated at each stage. This can be a drain on resources and, ultimately, time to market.

What are the challenges of software validation in scope, and how can the Cognition Cockpit Validation Kit help? The Validation Kit slide set breaks down the major challenges of validation and how the kit resolves these issues for the Cognition Cockpit™ platform, a robust design controls and risk management solution for medical device, pharmaceutical, and combination product teams.

Features of the Cockpit Validation Kit include:

  • Compliance with 21 CFR 820.50 subpart E, 21 CFR 820.70(j), GAMP 5, and AAMI TIR36:2007
  • Support for IQ/OQ/PQ testing (where applicable)
  • Modular capability for configuration validation
  • Access to validation Subject Matter Experts for advice and support throughout the validation and revalidation process

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