Guided Compliance for Life Sciences
Compass’s Guided Compliance approach guides teams through their product development and regulatory processes and makes the creation of submission deliverables a fluid part of daily tasks.
In today’s changing regulatory environment, rapid compliance is more important than ever. Efficiently demonstrating system safety and efficacy is a top challenge facing medical product development teams.
With Compass you can use out-of-the-box templates for industry standards or define your own process templates and standard operating procedures.
Compass is key to your Quality Management System strategy
Efficiently demonstrating system safety and efficacy is a top challenge facing medical product development teams in today’s changing regulatory environment. It is key to market your technologies faster and set yourself apart from your competitors.
Executive Management
“Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.
Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.” – 21 CFR 820.20
Risk Management
“The manufacturer shall establish, document, and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.” – ISO 14971
Design Control
“Each manufacturer of any class III or class II device, and [some] class I devices … shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.” – 21 CFR 820.30
Document Control
“Each manufacturer shall establish and maintain procedures to control all required documents… The procedures shall provide for the following: (a) Document approval and distribution… [and] (b) Document changes.” – 21 CFR 820.40
Introducing Compass as a Guided Compliance Platform
Compass is a product development compliance and commercialization platform used to aid in the development of medical devices, pharmaceuticals, and combination products. Compass allows teams to trace the product development process from concept through commercialization and into post-market.
REGULATORY COMPLIANCE
Compass is designed with compliance in mind. Built-in features enable compliance as defined by critical standards relating to medical device and pharmaceutical design. Standards include 21 CFR 820, ISO 14971, and IEC 62366, to name a few.
SOFTWARE-AS-A-SERVICE (SAAS)
Compass is hosted on a secure SaaS environment provided by Synergio. Synergio’s SaaS offerings are compliant with SSAE 16 and 21 CFR Part 11. Access your project from a secure, shared environment made for collaboration.
TEMPLATED APPROACH
Compass offers a guided approach to complying with many standards. This method ensures consistency with the regulations and standards throughout all projects. It also produces compliant, submission-ready documents that can be used for regulatory deliverables.
REQUIREMENTS MANAGEMENT
From Market Requirements, to User Needs, to System and Regulatory requirements through to Design Outputs: Compass guides teams to manage all aspects of requirements during a project. Requirements can be imported or created within Compass, allowing teams to work with them in a central location.
TOTAL TRACEABILITY
Compass provides a full, visual traceability mechanism to see connections from product inception to completion of testing. Compass’s unique linking ability allows teams to easily create connections between Requirements, Tests, Risks and Mitigations. These connections are then shown in multiple dashboard views throughout the project.
RISK MANAGEMENT
Compass provides out-of-the-box templates for PHA, FMEA, FTA, and more. Scoring and color matrix options allow you to tailor the Compass experience. Risk calculations are done within the platform, reducing the room for error. The built-in risk functions can be configured to suit medical device or pharmaceutical products.
