Powerful and Unique Trace Functionality
Designed Specifically for Medical Device Companies
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. Compass trace matrices can be adapted to an organization’s SOP’s and can be exported for reporting purposes.
Why it matters: 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.
“Before Cognition we were manually creating data and data connections that were maintained in paper DHFs that were difficult to scale. Now we are able to create the same data and links in a way that allows Zimmer Biomet to easily maintain large trace matrices. The product has helped us to significantly improve quality, accuracy, and efficiency in our product development process.”
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.
Why it matters: 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.
At Cognition, we place high emphasis on the value of treating risk management properly in the design control process. To dig deeper into our view of the right approach, read the article published in MDDI Complying with ISO 14971:2019 by our Compass, Product Line Manager, Ben Higgitt.
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.
Why it matters: 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.
Why it matters: 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.
Why Choose Compass for Traceability?
- A 360-degree view of the project – risks, requirements, and tests - real-time and historic for the most informed planning, development, and impact analysis
- Audit and submission-ready content – trace matrices can be exported as documents to support auditing, regulatory submissions, or for process inquiries;
- Guided compliance – pre-configured templates and traces are built to support compliance with relevant industry standards like ISO 13485, ISO 14971, 21 CFR 820.30 and Part 11, and IEC 13485
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