News & Events

Quality Management

17 November: Polarion Autumn Conference – online

Are you a user of Polarion ALM? Are you looking for solutions to your problems and are curious to exchange experiences with experts like you? This year’s Polarion Autumn Conference offers you presentations and experience reports from users for users. This year’s conference focuses on „DevOps in adapting, deploying and using Polarion“. 

Further information on registration and agenda can be found here.

From 13:30 – 14:20, Dr Janine Hofmann, QM/RA at BECOM AG and Sven Wittorf, Managing Director of Medsoto GmbH will speak on the topic of „Parallel use of Azure DevOps and Polarion – ensuring end-to-end traceability to test results“: Azure DevOps supports software development and offers all functionalities to fully map testing as well. However, the tool has weaknesses when it comes to exporting test results, especially when human-readable, traceable and long-term archivable documentation has to be generated in a regulated environment. The same applies to tracing the tests to requirements. Polarion ALM has clear advantages in these points, which is why many companies use both tools. In this article we present a project in which a seamless integration of the two tools was implemented up to the synchronisation of test runs and test results. We will first look at how the process requirements were mapped in the respective tools and what this means for the connection of the two tools. Finally, we show the solution that was created and report on the experience we have gained so far in this project.

20 October: The Digital Red Thread in Quality and Regulatory Affairs Management

At this event, Christian Johner and Andrea Seeck from the Johner Institute and Sven Wittorf from Medsoto GmbH will address the digital red thread in quality and regulatory affairs management for manufacturers of medical technology and products. 

Registration Siemens Life Science Forums.

The focus is on the continuous data flow and the consistency and traceability of information and documents. Christian Johner opens the event with the contribution „Digitalisation and monitoring of standards“ from the Johner Institute. Andrea Seeck picks up the thread and shows how the automated monitoring of regulations helps to ensure compliant products and processes. Sven Wittorf links this digital QM/RA thread with practical experience from R&D in his contribution „Integrating regulatory requirements into the development process“.

Finally, there will be enough time for questions.

Agenda

15:00 – 15:15: Welcome address 15:15 – 15:45: Impulse Talk „Digital transformation of regulatory processes“ – Prof. Dr. Johner 15:45 – 16:15: Industry Talk „Automated monitoring of regulations ensure compliant products and processes“ – Dr. Andrea Seeck, Johner Institute 16:15 – 16:45: TechTalk „Integrating regulatory requirements into the development process“ – Sven Wittorf, Medsoto GmbH 16:45 – 17:00: Discussion & Questions