🚀 2023.2
Release Notes
✨ Features
R2302_01: Change History
What changes have been made since I last viewed the task? Who added or removed a particular piece of information from the task? When was this information added? In the course of editing and review-processes, it is always useful to be able to track changes that have been made. To enable you to track adjustments to the technical documentation at any time when working in a team, the "Change History" area is now available for all tasks.
R2302_02: Technical Documentation
To submit the entire Technical Documentation to the Notified Body, you can now download it as an entire report from BAYOOSOFT Themis. All information in the system as well as uploaded files are then compiled in the required folder structure for the Technical Documentation and made available as a "zip" file.
R2302_03: Team Communication Through Notifications
When you assign a task to another person, comment on it or remove the person from the task, he or she will receive a notification, which can be viewed in the notification overview (top right of the view). If a team member is assigned to a specific task and a comment is created in that task, they will also receive a notification.
📐 Enhancements
E2302_01: Predefined Links
In the requirements for Technical Documentation, MDR 2017/745 often refers to specific documentation components on which a document is based or which adopt the corresponding information (e.g. Intended Use or Instruction of Use). These predefined links are now available bidirectionally inBAYOOSOFT Themis and are displayed to you as a relationship - both at the Instruction of Use and in the referenced tasks the links are available.
E2302_02: Undo Changes
As long as you are actively working on a task, you can undo all the changes you have made using the "Undo" button.
E2302_03: Enhancing Security by Concretizing Password Rules
In order to permanently protect your data from unauthorized access, we are continuously optimizing our data protection guidelines. Therefore, passwords require a minimum length of 14 characters from now on.
🐞 Bugfixes
Minor Bugfixes
Changes to the System Requirements
S2302_01: On Premise Deployment
BAYOOSOFT Themis can now be operated in the BAYOOSOFT cloud environment or on premise in your infrastructure, as desired. This requires a Kubernetes environment. For further information regarding system requirements, please contact us by mail: themis@bayoosoft.com
Product Release Approval
The features, enhancements and bug fixes listed above have been approved based on the following steps of the release process.
| # | Milestone | Responsibility | Date |
|---|---|---|---|
| 1 | Unit Tests: All unit tests were successfully executed after the implementation was completed. | Development Team | 14.06.2023 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 16.06.2023 |
| 3 | Performance Qualification: The system has been verified against the PQ tests to proof that it meets the requirements, technical specifications and assessment criteria of Software Validation acc. to ISO 13485. | Validation Team | 28.06.2023 |
| 4 | Release Approval: Based on the verification results of previous steps, the features, enhancements and bug fixes were approved and released as a new version of the product. | Product Manager | 28.06.2023 |
This release process is documented to comply with the BAYOOSOFT quality management system.
Do you have any further questions?
Here you will find the contact details of our Service Team.