Compass' Design Controls Template combines best practices with the standard itself

21 CFR 820.30 outlines the regulations for Design Control of medical devices. The regulation is broken up into ten subsections detailing the tasks necessary to be compliant. The guidance is written in a way that leaves it open for interpretation.

Compass 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.

Allocation is made easy with Compass. 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.

Compass 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 Compass for easy traceability.

The Design Controls templates provided in Compass 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.

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.