Polarion
Traceability matrices on Adrenaline
Getting the Most From Polarion ALM
Siemens Polarion aligns all moving parts of developing product specifications, from inception through post-production and post-marketing surveillance.
We’ll make your transition to Polarion painless, configuring the tool to support the way you work and your own Quality Management System (QMS), helping you migrate legacy data into the system, and training your staff – engineers and non-technical personnel alike – to use Polarion for more effective collaboration.
We’ll also ensure that the platform is integrated with your core software, including Jira, for a streamlined, automated, optimized, compliant system that allows you to effortlessly stay on top of your design.
Why Polarion ALM?
Polarion provides you with flexibility, continuity and turnkey compliance. The following benefits top our list of why Polarion is a tool of choice for quality management:
- It transitions seamlessly between a Word-like editor and structured data entry, accommodating a wide range of user preferences and making it easy to onboard new users of varying technical abilities for better collaboration organization-wide.
- It provides a baseline of product design elements and continuously stores snapshots of the complete design file, so pulling historical data is a snap.
- It includes out-of-the-box compliance with FDA CFR 21 Part 11.
- The software includes free templates, which are configured specifically to support:
- Medical device development up to Class 3, in line with FDA and EU requirements
- Non-product Computer Systems Validation (GAMP 5 compatible)
- Polarion can be integrated with external systems – we like its out-of-the-box integration with Jira in particular.
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What does eQMS success looks like?
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Raymond, Vice President of Regulatory Affairs and Quality
Everything is streamlined, and the time savings have been incredible. Now, compliance-related tasks are getting done in 1/5th the time they used to take. In vitro diagnostics (IVD) medical device organisation and a clinical laboratory located in Massachusetts.
We’d love to learn more about your project.