🚀 2024.2
Release Notes
✨ Features
F2402_01: Digital management of QM/ISM processes
A certified QM/ISM system demonstrates to customers and regulators that an organization is taking the necessary steps to ensure that the developed products are safe and effective. The implementation of such a system is intended to increase efficiency and reduce the risks of recalls and claims. However, management systems are often implemented in independent documents or wiki tools, which either make team collaboration difficult or do not allow processes to be versioned in a way that is traceable over time.
In order to enable the creation and maintenance of the associated management systems in addition to the creation of technical documentation in a digital, legally compliant and team-based manner, we have transferred these main principles of BAYOOSOFT Themis to a new electronic management system. This supports you in handling your processes, work instructions, attachments and forms and prevents redundancies by centralizing your documents. Each document is represented as a task, which are linked to each other, thus ensuring a single source of truth.
This package "Management Systems" can be purchased online at our Onlineshop
F2402_02: ISO 13485 Documentation Guide
An ISO 13485 Guide is now available in your BAYOOSOFT Themis. This supports you in creating your quality management system (QMS) in accordance with all the requirements of ISO 13485 and prevents redundancies by centralizing your documents. You receive convenient task-based user guidance that guides you through the entire documentation process.
With the ISO 13485 guideline in combination with the digital management of your quality management system, you gain permanent transparency in fulfilling the requirements by directly linking the standard requirements with your standard operating procedures. If your processes are changed, you can ensure at any time that the changes still meet the requirements of the standard. At the same time, you can establish a direct link to your processes during an audit if you have questions about compliance with certain chapters of the standard.
ISO 13485 Guide is available to you as a stand-alone package and can be purchased accordingly by visiting our Onlineshop
F2402_03: ISO 27001 Documentation Guide
ASimilar to the ISO 13485 Guide, the ISO 27001 Guide supports you in creating your information security management system (ISMS) in accordance with all the requirements of ISO 27001. Here, too, the interaction with the digital management of your processes enables you to have permanent transparency as to which of your guidelines meet the requirements of the standard.
In addition to the requirements for an information security management system, the ISO 27001 Guide includes the information security measures referenced in the annex, so that these can also be considered in your information security efforts.
ISO 27001 Guide is available to you as a stand-alone package and can be purchased accordingly by visiting our Onlineshop
F2402_04: ISO 9001 Documentation Guide
In addition to ISO 13485 and ISO 27001, the ISO 9001 Guide provides you with all the requirements for a Quality Management System (QMS) of ISO 9001, including amendment 1 from 2024. Again, the integration with digital process management enables you to maintain ongoing transparency regarding which of your policies meet the normative requirements
ISO 9001 Guide is available to you as a stand-alone package and can be purchased accordingly by visiting our Onlineshop
F2402_05: Risk management according to ISO 14971
The internationally valid ISO 14971 standard specifies a procedure for identifying, assessing, evaluating and controlling the hazards of medical devices and their accessories as well as monitoring the effectiveness of these controls. The requirements of this standard for risk management are now fully integrated for the creation of a standard-compliant risk management file. This is done in a clearly structured procedure based on the process steps of the standard. Risk analysis, assessment and control are carried out using the common Preliminary Hazard Analysis (PHA).
Risk management is divided into the following modules to enable gradual versioning.
- Risk management plan
- Risk analysis, assessment and control
- Overall residual risk
- Review of risk management
- Activities in the production of downstream phases
All these modules are part of the Risk Pack, which can be purchased from our Onlineshop
F2401_06: Checklist for compliance with the Essential Health and Safety Requirements according to (EU) Regulation 2023/1230 on machinery
Regulation (EU) 2023/1230 has been applicable to the manufacture and placing on the market of machinery in Europe since June 14, 2023. Annex III of this regulation defines essential health and safety requirements to ensure a high level of health and safety protection.
BAYOOSOFT Themis now enables you to carry out conformity assessment with these requirements. In order to provide proof of the conformity of your machines, you now have the option of documenting the applicability of each requirement and the methods for verification, as well as storing the standards you have applied and outputting everything together in a report. You can also store the norms and standards you have applied and output everything together in one report.
📐 Enhancements
E2402_01: Grouping tasks
All Guidance Module documents are presented as tasks so that they can be processed in a structured manner. These are assigned to chapters in accordance with the underlying regulations. For a better overview, it is now possible to display these tasks grouped according to these chapters. In this way, you will initially see collapsed chapters which, when expanded, display the individual tasks.
Tasks can be grouped using the local page options. In addition to chapters, grouping can also be based on status or assigned persons.
E2402_02: Delete tasks
If tasks, e.g. requirements, were created in the wrong way, they can now be removed from the database in the extended menu. If these tasks were linked to other tasks, the link is also removed accordingly.
E2402_03: Requirements engineering - customizable prioritization and additional inputs
Previously, the specifications for priority, effort and test types were predefined in the requirements engineering module. To offer you more flexibility, it is now possible to define these individually in each project. In addition to “Requirements and tests”, there is now a further page “Requirements” on which the options to be used can be configured using the familiar task-based approach.
🐞 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 | 27.05.2024 |
| 2 | Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification. | Service Team | 28.06.2024 |
| 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 | 02.07.2024 |
| 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 | 03.07.2024 |
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.