🚀 2024.3
Release Notes
✨ Features
F2403_01: Revised Versioning Concept
With the new release 2024.3, the versioning concept in BAYOOSOFT Themis has been revised. From now on, you can individually version your documents, finalize and release documents, manage versions of the entire documentation, and add documents to your project retroactively. You can manage your project on a new overview page.
These new functions are explained in more detail below.
New Overview Page for Managing the Open Project
On the new overview page, you can see the versioning status of all documents in your project at a glance. By clicking on a corresponding document, you will be taken directly to the detailed view of the document.
With the appropriate permissions, you can use the following functions on this page:
- Create new versions of documents
- Manage permissions of a document
- Edit document details (e.g., version number and description)
- Change document status (e.g., New, In Progress)
- Finalize and possibly release documents
- View and open older versions of a document
- Create new versions of the entire documentation
- Edit details of the entire documentation
- Select older versions of the entire documentation and view the corresponding versions of the included documents at that time.
- Add documents to the project
Individually Version Documents
From now on, documents can be individually versioned. This means that you can control the versioning of a document independently of other documents in your project and, for example, create a new version of the risk analysis without affecting other documents such as the risk management plan.
Finalize and Release Documents
Documents can be finalized and released. A finalized document, whether with or without release, can no longer be edited. To perform this operation, appropriate permission is required, which can be granted through the new role Document Releasing Person.
Manage Versions of the Entire Documentation
With the new version of Themis, you can now version your entire documentation in your project. The entire documentation represents the combination of all your documents. A version of the entire documentation always contains specific versions of the included documents. Through versioning, you can record which documents in which version were included in your project at a specific time.
By finalizing a version of the entire documentation, it is frozen which versions of the documents are included.
Add Documents to a Project Retrospectively
From now on, documents can be added to existing projects.
Revised Dialog for Creating Projects
The dialog for creating projects has been revised and now consists of several steps.
F2403_02: IEC 60601-1 for Medical Electrical Equipment
With the new release 2024.3, the IEC 60601-1 standard for medical electrical equipment is integrated into BAYOOSOFT Themis. The standard contains requirements for the safety and essential performance of medical electrical equipment. To demonstrate the conformity of your medical devices, you now have the option to record the applicability of each requirement as well as the methods for verification. You can also document the standards and norms you have applied and generate a report with all this information.
📐 Enhancements
E2403_01: Predefined References to Other Licensed Documents
When a document references another document by definition, e.g., from the "MDR Technical Documentation" to the Risk Management Plan, a link to the corresponding document is displayed in Themis. It is still possible to upload files at these points, and the link is only displayed if the corresponding document is present in the project.
E2403_02: User Interface Improvements for Linking
The user interface for linking tasks has been improved:
- The display of linked tasks has been made more compact.
- The last selected link type is preselected for new links.
- In addition to an existing task, a new task can now also be created and linked.
E2403_03: License Agreement and Privacy Policy Available in Help
The license agreement and privacy policy are now always available in the help section of BAYOOSOFT Themis.
E2403_04: Legend in Hierarchy View
A legend has been added to the hierarchy view in BAYOOSOFT Themis, explaining the meaning of the various symbols.
E2403_05: Automatic Assignments to Support the Workflow
To avoid interrupting the workflow, tasks are automatically assigned to the creator when they are created. Additionally, the person who adds a document to a project automatically receives permission to edit that document.
E2403_06: Simplified Selection of Logged-In Account for Assignments
To simplify the selection of the logged-in account for assignments, it now appears at the top of the selection list.
🐞 Bugfixes
B2403_01: Changes to Links Displayed in the History of Both Tasks
Previously, a change to a link $$was only displayed in the change history of the open task. Now the change is also displayed in the history of the linked task.
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 | 09.10.2024 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 15.11.2024 |
| 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 | 19.11.2024 |
| 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 | 20.11.2024 |
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.