Compass as a Guided Compliance Platform
Compass’s Guided Compliance for Life Sciences approach guides teams through their product development and regulatory processes, thus making the creation of submission deliverables a fluid part of daily tasks.
Use out-of-the-box templates for industry standards or define your own process templates and standard operating procedures (SOP).
- Automate traceability to ensure consistency throughout all development artefacts
- Automate the creation of submission deliverables
- Embed quality system templates into the daily workflow
- Baseline your entire platform
What is the impact of a powerful product development platform?
A Cognition-Epic Sciences, Inc. Case Study
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Compass's pre-defined templates
Compass provides sets of pre-defined online templates that allow for a simple, guided environment to complete exercises required for regulatory submissions. The templates live inside the Cockpit Platform, which is the engine powering them. Templates are updated from time to time to maintain consistency with updated standards and regulations.
All content created within the template is captured, stored, and managed in the secure underlying database, allowing content to later feed into other templates that are part of the development process. This progression through the guided templates builds a set of deliverables suitable for both FDA and EU Notified Body submissions.
The PHA template allows teams to create a Preliminary Hazard Analysis by defining a list of perspectives and questions proposed by the standard. The PHA Template supports pre-populated Harm and Hazard libraries.
- EN ISO 14971:2012 – Application of Risk Management to Medical Devices
- IEC 62366-1:2015 – Application of Usability Engineering to Medical Devices
The Design Controls template combines FDA best practices with the standard itself, leaving little room for error in the design process.
This template was created to give teams an easy way to start creating and capturing requirements, validation tests, and verification tests in accordance with 21 CFR 820.30, which outlines the regulations for Design Control of medical devices.
The FMEA templates guide teams through completion of FMEA exercises for dFMEA and pFMEA.
Compass’s FMEA templates are configurable to meet the EN ISO 14971:2012 – Application of Risk Management to Medical Devices – regulations.
USABILITY ENGINEERING TEMPLATE
The Usability Engineering Template guides teams to reduce use-related problems that contribute to or may cause risk.
It assists in defining and understanding the use of the device and identifying potential use-related risks. Results from Formative testing can be used to improve the design.