🚀 2023.1

Release Notes

BAYOOSOFT THEMIS – The Future of Technical Documentation

The working world is becoming increasingly volatile as regulatory requirements continue to increase. Issues such as collaboration, growing teams and working across locations are now commonplace in the world of medical device manufacturers. This is exactly why we are rethinking the way we approach technical documentation. The result is called BAYOOSOFT Themis - our web-based software solution for your technical documentation. Our vision? Your documents will be traceable, even if there are overlapping processes, redundant data and inconsistencies can be avoided. We enable teams to collaborate more effectively with each other and at the same time manage large amounts of data in a meaningful way. This is exactly why we focus on the teamwork, digitalization and compliance aspects of BAYOOSOFT Themis.

THEMIS DOCUMENTATION GUIDE

Thanks to our many years of experience in creating technical documentation for medical devices, which we have gathered since 1998 with BAYOOSOFT Risk Manager, THEMIS DOCUMENTATION GUIDE is now available to you. It supports you in creating your technical documentation according to all the requirements of the Medical Device Regulation 2017/745 and prevents duplication of effort by centralizing your documents. Each document is represented as a task, and these tasks are interlinked, thus ensuring a single source of truth. After completion, you will receive the initial document for the Notified Body, which bundles all individual documents.

BAYOOSOFT THEMIS DOCUMENTATION GUIDE is the start of a new direction that will make the creation of technical documents easier and less complex. On this basis, BAYOOSOFT Themis will be expanded into a combination of editing work and document management system. The uploaded individual documents can be edited directly using the templates. Comprehensive processes, such as risk management, are first linked to the BAYOOSOFT Risk Manager and then lifted piece by piece to the Themis web platform. This gives you complete technical documentation - web-based and digital, with a focus on teamwork and compliance with current standards - and without the need to edit numerous Word and Excel files in parallel.

✨ Features

General basic functions

F2301_01: Structured navigation through the requirements of technical documentation

The THEMIS DOCUMENTATION GUIDE digitalizes processes for the creation of technical documentation through a web-based, structured procedure. A complete and structured guideline based on the Medical Device Regulation 2017/745 Annex II guides you through the necessary Technical Documentation Medical Devices up to the submission to the Notified Body. The application integrates into your existing regulatory processes and promotes them intuitively. The tabular view provides free sorting and filtering of the individual requirements.

F2301_02: Task-based approach

Task-based work in the THEMIS DOCUMENTATION GUIDE enables you to process regulatory requirements in a structured manner. Each requirement of the technical documentation is mapped as a single task, which are logically linked to each other and thus ensure a single source of facts. In addition, each task has its own unique ID that cannot be changed manually, so that you can track all changes on a task-by-task basis and allocate them without error.

F2301_03: Filter function for tasks

With the control bar above the elements, you can easily manage the elements displayed to you. For example, you can filter out to show only the elements assigned to you or see only the desired section of the technical documentation. You can also adjust the display options for each column here.

F2301_04: Save Functions

The Save button was introduced to ensure safe working at all times. If you leave a task without saving, the system will automatically notify you to avoid data loss.

F2301_05: Cloud or on-premise use of the validated software solution

BAYOOSOFT THEMIS is a web-based software solution so that your employees can access the environment quickly and easily from all locations. You have a choice when it comes to deploying your organization-specific environment:

• you can run an instance of the application in your own infrastructure and use the provided pre-validation files, fully validated to ISO 13485 standards,
• or we take over the operation of your instance in our cloud environment and ensure a validated environment including all updates for you.

Compliance

F2301_06: Medical Device Regulation 2017/745

The THEMIS DOCUMENTATION GUIDE covers all requirements of the Medical Device Regulation 2017/745 for the technical documentation of medical devices. Teamwork

F2301_07: User assignment at task level

THEMIS DOCUMENTATION GUIDE It is structured on a task basis. For each requirement that needs to be fulfilled, there is a task with a processing status and a responsible person. In this way, you can see at any time which person has made the change and avoid fragmentation of responsibility in the project. You keep an overview of your project team and have a controlling tool for resource planning and efficiency in the creation of your technical documentation.

F2301_08: Collaboration through chat & comment functions

Build synergy effects in your teams even further and use the possibility to carry out your editorial work for the technical documentation in parallel. Use the functions of comments for your required communication and dispense with queries by mail, chat or telephone.

F2301_09: Multi-user access

Collaborating on projects helps you create synergies in the documentation process. Multi-user access allows several employees to work simultaneously on a project across departments. BAYOOSOFT THEMIS ensures that parallel working works without overwriting other work results by assigning individual elements to a specific editor. The own assignment of tasks of another editor is only possible after a warning of the system.

F2301_10: Progress bar

You can see the current status of your work processes and keep track of the status of individual tasks via progress bars. In later versions of BAYOOSOFT THEMIS, these progress bars will be available in a more granular way to individual modules and teams.

Digitalization

F2301_11: Status Indicators & Item Versioning

With the help of status indicators you get a live update about your project. The status of the elements has a direct influence on the display of your project progress, but acts not only as a monitoring element, but also as an important intermediate step in the release cycle of the individual elements. Use the status indicators as an important indication of the current editing status of your technical documentation.

F2301_12: Document management at task level

For each proof of your technical documentation required by the authorities, a specific document upload is available with which you can directly add your required documents. This way you avoid keeping different documents and versions and ensure that your complete documentation is in one place.

F2301_13: Audit Trail

With BAYOOSOFT THEMIS you will not miss any changes to your technical documentation. With the help of the audit trail, every change in the entire system is automatically recorded and saved. This way you avoid information loss and undocumented modifications.

F2301_14: Task-based report generation

For each task and thus each MDR requirement, BAYOOSOFT THEMIS gives you the option of creating a single report. This is automatically marked and transferred to your documents without causing any loss of information.

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	31.03.2023
2	Sprint Acceptance Tests: All listed user stories and bugs were implemented according to the functional specification.	Service Team	31.03.2023
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	03.04.2023
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	03.04.2023

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.