Simplify Your Validation with the Cockpit® Validation Kit
Spend more time on product development and less on validating third-party software solutions. The Cockpit Validation Kit (CVK) increases the speed of your validation efforts and makes meeting compliance requirements simpler.
The Cockpit Platform comes with a complete out-of-the-box validation report, saving your users time and effort.
Each Cockpit release provides CVK users with a full, updated documentation set, reducing time needed to complete validation efforts.
The CVK has comprehensive validation templates for test plans, protocols, requirements, and execution records.
Within each template, you can easily enter your validation requirements and expected outputs. These can be seamlessly traced to all your test cases.
VALIDATION SERVICES & SUPPORT
Cognition's Validation Subject Matter Experts (SMEs) create, run, and maintain your validation environment. They are available to assist, support, and advise you with initial installation, as well as throughout your design stages. As part of our services, we work with outside agencies if necessary.
Compliance with the Validation Kit
The Cockpit Validation Kit meets the following standards, regulations, and guidances:
- 21 CFR 820.50 Subpart E – Purchasing Controls
- 21 CFR 820.70(i) – Automated Processes
- AAMI TIR36-2007 – Validation of Software for Regulated Processes
- GAMP® 5
- FDA General Principles of Software Validation, Section 6.3
- 21 CFR Part 11 – Electronic Records
With the Cockpit Validation Kit, you can have confidence your Cockpit environment meets full regulatory compliance.
IQ, OQ, PQ
The Cockpit Platform's cloud environment empowers validation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) based on AAMI standards:
- IQ — Ensure the Cockpit Platform is installed and operating as intended. Cognition validates the Cockpit against pre-defined sets of intended use protocols.
- OQ — Verify the Cockpit Platform functions properly under normal/abnormal conditions and at limits of intended operation.
- PQ — Determine repeatability of software functions in the environment by intended users, where applicable.
Cognition will provide support for IQ, OQ, and PQ testing (where applicable).