Risk Pack Pro: Interactive Risk Management in Polarion – Compliant With Standards and With an Intuitive User Interface
With RiskPack Pro, you can integrate risk management digitally and directly into Polarion in compliance with ISO 14971. Interactive tables enable flexible views - so you only see what you really need. RiskPack Pro supports you in all phases of the risk management process and creates the documentation required by regulations. Use one tool for development, documentation, and risk management without disruptive media jumps. This gives you an overview of all dependencies on the development project, saves time, and prevents inconsistencies in your documentation. You always know how complete your risk management file is. This gives you the certainty that you have thought of everything for your audit.
Risk Policy and Risk Control Matrix
Use the Risk Policy page to define the severity and probability of occurrence values. With the help of the Risk Control Matrix page, you can keep track of the risks already identified concerning the acceptance level you have individually defined. These priorities are automatically embedded in the two LiveDocs Risk Management Plan and Report.
Interactive Tables
Edit and evaluate risks in interactive tables directly in Polarion. Use tailored views to manage and edit the information.
Full Traceability & Seamless Integration
Check the traceability of components or hazards all the way to the verification of the risk control measure. Add and change data directly in the editable table. The corresponding links are created automatically. Use data from existing Polarion projects: Link your risk management directly to your development or usability engineering process. Check and edit data across projects in one place.
Lean Data Model
With three interactive tables, you can keep an eye on the entire risk management process in accordance with 14971 - clearer and more convenient than ever before.
Risk Management Tasks
Use the prepared plans and tasks to track your progress and maintain an overview of the process. On the homepage, you will find a process cockpit to help you navigate the project and complete tasks.
Plan and Report
Use the prepared LiveDocs Risk Management Plan and Report to depict the essential contents of the risk management process. Combined with an export of the interactive tables, you can complete your ISO 14971-compliant documentation.
For more information, contact us at: info@medsoto.de.