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.
Siemens partner

As a biotechnology company in the health industry, we need to prove that we’re handling data in the most secure way possible.
RadBee improved our quality management system on a tight deadline. It was a very important project—essential to getting recertified—and RadBee delivered.

- Jasmine Beukema, VP Quality, SOPHiA GENETICS SA

[...]

Get in touch

Visit usSt John’s Innovation Centre, Cowley Road, Cambridge, CB4 0WS, United Kingdom
Call us+44 (0) 1223 234 992
Email usinfo@radbee.com

Blog

How Paperless Validation Makes a World of Difference to Your Medtech Company Success

How paperless validation makes a world of difference to pharma success

For many of the medtech and pharmaceutical companies I consult with, there’s a common clash of the validation systems “worlds” raging: traditional, “this is how we’ve always done it” paper documentation versus newer, tech-driven solutions. In order to effectively harmonize business processes company-wide, I argue that innovation is critical, as the challenge is not just […]

Sick of Repeating Yourself? Try Engineering Your Procedures in Confluence

Sick of repeating yourself? Try engineering your procedures in Confluence

Confluence is much more than a Wiki. As you become a power user of Confluence, there are many macros that can help simplify the process of writing better documents. Take for example, the Comala metadata plugin (free plugin for Confluence server). By providing a set of macros that allows you to easily define your metadata, and […]

Agile for GXP and Medtech

Agile for GXP and Medtech

These are exciting times to serve the life sciences sector – thanks to technological advances, innovations abound and progress marches on at a lightening-fast clip. Working with a wide variety of organisations, I see two very different types of teams searching for an answer to the same fundamental question: “How do I best do Agile […]

More posts