The Risk Module extends the base-risk functionality included in Cockpit Enterprise, specifically to provide enhanced support for the array of ISO 14971:2019 risk management processes.
LEXINGTON, Mass., May 25, 2022 /PRNewswire/ — Cognition Corporation, a leader in SaaS solutions for medical device and pharmaceutical product development and regulatory submissions has released a new Risk Module add-on for its Cockpit Enterprise Solution. The Risk Module extends the base-risk functionality included in Cockpit Enterprise, specifically to provide enhanced support for the array of ISO 14971:2019 risk management processes. It is designed to be able to ‘plug-in’ to existing Cockpit Enterprise implementations, delivering new risk functionality without affecting existing requirement/test data.This provides users the control to specify data sources and object filters where required in order to connect the risk data to existing project data.
“Our New Risk Module for Cockpit Enterprise enables us to effectively manage risk. The “plug-in” nature of the new risk module means we will have simpler implementations with faster benefits. Ultimately, we are saving time and seeing better risk management.”
– Ian Bennett, IT R&D Leader, Smith & Nephew
Key functionality of the Risk Module for Cockpit Enterprise include:
- Risk Management Plan
- Preliminary Hazard Analysis
- Design FMEA
- Product Risk Analysis
- aFMEA / Use Risk Analysis
- Data Libraries
“Through our work with customers, we have been involved with the implementation of a number of risk management processes. During this work, we identified common elements among these processes as well as variances in how these elements are identified, assessed, controlled and reported on. This is why we have developed a new Risk Module, as a subscription add-on, for Cockpit Enterprise. With the Risk Module, our customers are able to implement their individual risk processes and start utilizing risk functionality in Cockpit Enterprise faster.”
– Ben Higgitt, Product Line Manager, Cognition Corporation
Benefits of the Risk Module for Cockpit Enterprise include:
- Process Independence
- Faster Deployment
- Flexible Risk Environment Set Up
- Integrated Reporting and Analysis
- Workflow Availability
For more information on the Risk Module for Cockpit Enterprise, click here.
ABOUT COGNITION CORPORATION
Cognition develops, sells, and supports risk-first product development and compliance solutions for the medical device and pharmaceutical industries and is trusted by the world’s leading life sciences companies. Its Software-as-a-Service platform enables customers to structure their data and automate processes with built-in quality to save time and money and bring products to market faster. For more information, visit https://cognition.us/solutions/Cockpit-Enterprise/.
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SOURCE Cognition Corporation