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:

  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design History File

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

The Cockpit Platform makes authoring requirements—such as User Needs, Design Inputs, System and Regulatory Requirements, and Design Outputs, to name a few—simple using the pre-configured tables in the Design Controls Template. Users can easily and rapidly create numerous requirements in a single interface, streamlining this portion of the design process.

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If requirements already exist in an external program, like Microsoft Excel or Word, the platform provides a simple mechanism for import. Easily transition from the old pen-and-paper method to a unified database that provides real-time updates when collaborating.
Allocation is made easy with the Cockpit Platform. Out-of-the box tables allow for item allocation and connections to be made. These trace connections are used to automatically populate trace matrices used in deliverables.

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Cognition approaches Design Controls from the top down while incorporating verification and validation testing into every step. Cockpit supports validation testing of user needs and verification testing of all other requirements (system and regulatory requirements, device product requirements, and subsystem requirements). All tests are captured and managed within Cockpit for easy traceability.

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The Cockpit Platform records information about the test, whether it be validation or verification, and any requirements that are linked to it. Results and any additional comments or performance results are recorded for each requirement in accordance with 21 CFR 820.30. The ability to associate defects with test-requirement pairs is also supported. This enables teams to follow up postmarket by capturing complaints and enacting Corrective and Preventative Action (CAPA) per FDA regulations.
The Design Controls templates provided in the Cockpit Platform include a detailed set of out-of-the-box, non-editable trace matrices that can be exported to PDF for use as part of a larger submission. These trace tables automatically pull in information entered during the Design Controls exercise, building a larger picture of the numerous connections between requirement levels, as well as risks and tests.
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The Design Controls template comes with a comprehensive workflow that includes approvals, reviews, and electronic signatures as required by 21 CFR Part 11. The workflow allows for total document and item control for any given project. Completely permissions-based, the workflow restricts commands to only those who should be able to perform them. This ensures all aspects of the item are correct before it can be advanced in its process state. Workflow is configurable by users.
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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:

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WORKFLOW CONTROL

Take control of your Cockpit process with configurable roles and workflows.

NOTIFICATIONS

Gain immediate insight to changes or problems with built-in notification and email capabilities.

ELECTRONIC SIGNATURES

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.

SUBMISSION-READY ARTIFACTS

PDF submission-ready artifacts at the click of a button.