🚀 2023.3
Release Notes
✨ Features
R2303_01: Technical Documentation Guide IVDR
From now on, an IVDR Guide is available in BAYOOSOFT Themis. This supports you in creating your technical documentation according to all requirements of the IVDR 2017/746 and prevents redundancies by centralizing your documents. BAYOOSOFT Themis provides a comfortable task-based user guidance that guides you through the entire documentation process, ensuring a single source of truth. Upon completion, you will receive the basic document for the Notified Body, which bundles all individual documents.
R2303_02: Fine-tuned Rights Management
The new roles and rights concept takes user management to a new level. The "Team" page is now available for managing roles and rights. The assignment of rights is now much more fine-grained - this means your data is better protected. For a read-only access to projects (e.g. for the management level) the role "Observing Person" is provided. In addition, the new role "Approving Person" enables the release of tasks.
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R2303_03: Linking of Tasks Within a Module
Often the same issue or the same document is addressed/referenced in several places (example: the documentation for the chapter "Technical specification" is also required in the chapter "Electrical safety"). The possibility to link tasks within a project module (e.g. TD Guide MDR) allows you to establish relationships between individual chapters of the technical documentation. In addition to simple links, parent-child relationships and predecessor-successor relationships are also available. The links are included in the reports.
R2303_04: Task Approval
Review and approval are essential requirements for the creation of technical documentation. After approval, no more changes may be made to the documents. To enable this in BAYOOSOFT Themis, individual tasks of a project can run through these process steps based on status changes. Only persons who have been assigned the role "Approving Person" can approve tasks. Tasks that are in the "Approved" state can no longer be edited by persons with the "Editing Person" role until they have been released again by the " Approving Person" role or a new project version has been created.
📐 Enhancements
E2303_01: Simplified Access to the Current Documentation
The newly designed entry page provides a better overview and simplifies access. You will always be directed to the current project version (currently with the MDR / IVDR modules) and have quick access to the "Team" page as well as to the "Project Information" page via the menu item on the right. You can switch to other project versions via a drop-down menu.
🐞 Bugfixes
Minor Bugfixes
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 | 18.09.2023 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 19.09.2023 |
| 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 | 19.09.2023 |
| 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 | 20.09.2023 |
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.