Compass as product development and compliance platform
Compass 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
in time allotted to
in non-value added
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.
AUTOMATED TRACE MATRIX CREATION AND MANAGEMENT
Compass guides the development of best practice trace matrices with pre-configured templates – as design data is added, connections are automatically established.
Once set up, when changes are made, objects are automatically promulgated across every connection in a trace. When a change has the potential to impact dependent relationships in the trace, those relationships can be easily identified for resolution.
Automated processes make it easy to apply quality best practices across the trace to ensure every change is accounted for and nothing falls through the cracks – a master map and single point of truth where all actions and their impacts across a product’s development lifecycle are recorded.
INTEGRATED RISK MANAGEMENT
Compass tightly integrates risk management with requirements and test management, and uniquely manages all of the interactions in a single system.
As a result, the impact plus cause and effect of every change across every function is traced and accessible, not just requirements and tests.
By including risk as part of every action, rather than bringing in risk data from another system when needed, it provides for true accountability, auditability, impact analysis, and planning. It also properly treats risk management as we interpret that it is defined in ISO 14971
Compass’ trace matrices scale to tens of thousands of trace items consisting of any type of data – no matter the size of the trace or the size of the project, issues and impacts are instantly surfaced and presented to the user. Individual trace matrices can be combined to create a master trace of the entire development project.
Large and complex projects are the hardest to troubleshoot and manage – and are difficult to communicate to notified bodies – without smart, scalable, and accurate data management. It is common for a medical device to generate an overview trace of more than 10,000 data items which most systems cannot handle. Compass is explicitly designed to support this scale.
Compass can include data from outside of the current project, in trace matrices. This means that risk, requirements, and test data from data libraries can be re-used.
This capability enables organizations to save significant time and effort by re-using risk, requirements, and test data rather than recreating the same data points over and over again.
Request a demo
See How Compass Can Help You Get to Market Faster, With Complete Traceability.
"*" indicates required fields