Complete device design with total traceability from start to finish
The Cockpit Platform provides a built-in mechanism for tracking links between objects. The master trace table allows teams to see connections from User Needs and Design Inputs through to Validation and Verification testing.
Comply with 21 CFR 820.30 easily using the Cockpit Platform:
Feel confident in your design process
Generate your DHF directly in Cockpit. All work is done in a central location, accessible when needed.
See what has changed, by whom, and when with Cockpit’s full auditing options. Integrated workflows make approvals easy.
Export submission-ready documents directly to PDF from Cockpit with the click of a button.
Flowdown various levels of requirements directly in the tool. Everything is located in a central database.
Support for full Verification and Validation testing, allowing for creation of multiple test documents and protocols.
Cockpit provides integrated support for Engineering Change Requests throughout the design process.
Design Control Features
Cognition provides multiple templates to ensure regulatory compliance.
Cognition’s powerful guided approach to regulatory compliance is a combination of the base Cockpit Platform and a specialized set of templates created for specific standards. Cognition offers a template to complete the Design Controls exercises explained in 21 CFR 820.30. Download our white paper to learn more:
Take control of your Cockpit process with configurable roles and workflows.
Gain immediate insight to changes or problems with built-in notification and email capabilities.
Cockpit provides 21 CFR Part 11-compliant electronic signature capabilities.
EVERYTHING IS LINKED
From risks to mitigations to requirements to tests and more. Everything is linked and stored in the same Cockpit database.
FULL AUDIT TRAIL
See what changed, by whom, and when with Cockpit’s full auditing options.
PDF submission-ready artifacts at the click of a button.