Compass' Template for Design Controls
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.
DESIGN AND DEVELOPMENT PLANNING
The Design Controls Template can provide a location for you to enter all the necessary information required by this subsection.
The Design Controls Template provides a simple way for you to capture design inputs.
The Design Controls Template provides a simple way for you to flow down from design inputs all the way down to design outputs. Compass makes creation and allocation of design outputs simple. Built-in trace matrices provide a top-level view of all connections made within the template.
Compass provides a comprehensive review feature, allowing you and your team to systematically review every aspect of your design control plan. Configurable workflow capabilities and Engineering Change Requests allow you more flexibility in how reviews are created and executed. Compass includes support for electronic signatures.
Verification tests can be created for system requirements, device product requirements, subsytem requirements, and design outputs, or tests can be linked in from an external system using the open API.
The template provides an easy way for you to enter validation tests and allocate them to the appropriate User Needs. Test results can be marked and stored into the Compass database using simple UI commands. Full test results are easily exportable for use in regulatory submissions.
The information generated by the template and stored in Compass can be used to facilitate the design transfer process.
The template facilitates design change in the design control process by supporting the change request processes as well as electronic signatures as part of configurable workflows.
DESIGN HISTORY FILE
The Design Controls Template automatically generates multiple trace tables showing connections between design inputs, design outputs and their tests in the project. These trace tables can be exported to PDF, Word, or Excel and included as part of the Design History File (DHF) submitted to a Notified Body.
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