August 2025

New handbook entries and important access control updates

We hope you’re having a productive week! Below you’ll find a summary of new entries in the meddevo handbook and important updates about roles and access control as we prepare for upcoming changes.

Bug Reporting

To make it easier for everyone to report bugs effectively, we’ve published a new handbook article. Please remember: Accurate and detailed bug descriptions are essential for our team to resolve your issues as quickly and thoroughly as possible. The clearer your report, the faster we can act! Visit the bug reporting guidelines in English or German.

Support and Problem-Solving

Running into issues? Our latest handbook addition explains how the meddevo support process works and shares sensible steps to resolve common problems. It’s a handy reference for troubleshooting and knowing when to contact our team. Access it in English or German.

Compliance Center

We’ve added a section dedicated to our Compliance Center, now available in the handbook. This overview is designed to support your audit work, document management, and preparation for regulatory conformity. See the details in English or German.

Role and Access Control Changes: Preparing for the New Licensing Model

As part of our preparations for a new licensing model, we are streamlining our role system in dytab. The old, technical roles (such as “Content Creator” or “Document Reviewer”) have been replaced with task-driven roles like Clinical Affairs, DMS & Approval, eTD Full User, Post-Market Surveillance, QM, Research & Development, and Submissions/Registrations. “Administrator” and “Read only” roles remain unchanged.

For now, all these new roles provide the same permissions as “eTD Full User”. The reason behind this change is to simplify user management by aligning roles with typical job functions, making it easier to choose the right one for your responsibilities. This adjustment is a preparatory step, and further refinements will follow as the licence model evolves.

📢 What you should do now: Your Key Users / Administrators should review the roles each user has and switch them to the most appropriate of the new roles. If you have questions about which role fits best, don’t hesitate to reach out. The former roles are still available in the system for now, but we kindly ask that you complete the transition soon for a smoother experience moving forward.

Validation Not Affected

In line with our risk-based approach, all bug fixes, updates, and minor changes made to the system do not affect the current system validation. But please check your own validation status, since your processes might differentiate some things individually.