An end to documentation chaos

Your single source of truth for process-guided document creation and networked information

BAYOOSOFT - Unsere Zufriedenen Kunden

Do you know the pressure? Manual documentation processes eat up valuable time, carry the risk of errors and make audits a nerve-wracking affair. Information is spread across countless documents, the overview is quickly lost and the constant worry of overlooking a requirement puts a strain on your team. Particularly in regulated industries, complete, consistent and traceable documentation is not just a requirement, but crucial to your success.

Traditional document management systems (DMS) often focus solely on the management and archiving of entire files. But BAYOOSOFT Themis takes it a decisive step further: We focus on actively designing and structuring your documentation. We guide you through the creation of your content in a process-oriented manner, transform disparate information into a true single source of truth, and enable you to perform efficient editorial work that goes far beyond simply filing documents.

BAYOOSOFT Themis - Technische Dokumentation Neu gedacht

Your direct path to a solution: Try BAYOOSOFT Themis for free for 1 month

See the benefits for yourself. Get BAYOOSOFT Themis directly from our online store and try the solution for one month free of charge—with no obligation.

Single Source of Truth

Say goodbye to redundant data and inconsistent information. With Themis, you can bundle all documentation content in a central, always up-to-date single source of truth for maximum efficiency.

Digital Technical Documentation

Speed up your product approvals and master audits with confidence. With Themis, you can create your technical documentation in accordance with MDR/IVDR in a process-guided and seamless digital format.

Digital QMS & ISMS

Optimize the implementation and maintenance of your management systems. With Themis, you can network processes and requirements for an audit-proof and dynamic QM/ISMS.

No time to inform yourself?

Join our free webinars and let our experts explain everything there is to know about BAYOOSOFT Themis.

BAYOOSOFT Themis: Your Benefits at a Glance

BAYOOSOFT_Themis_MDR_Task_Uebersicht
BAYOOSOFT Themis – Screenshot TD-Workflow: Freigabeschritte im Überblick
BAYOOSOFT Themis – Screenshot: Tasks mit Dokumenten verknüpfen
BAYOOSOFT Themis – Screenshot: Task-Verlinkungen effizient nutzen
BAYOOSOFT Themis – Screenshot: Prozesse und Standardarbeitsanweisungen verwalten
BAYOOSOFT Themis – Screenshot Projektübersicht: Detailansicht der Dokumentversionen
BAYOOSOFT Themis – Screenshot Projektübersicht: Dokumente und Versionierung im Blick
BAYOOSOFT Themis – Screenshot: Prozesse und Standardarbeitsanweisungen verwalten
BAYOOSOFT Themis – Screenshot AuditTrail: Änderungshistorie nachvollziehen
  • Single source of truth
    All information centralized, networked and without redundancies

  • Process-guided document creation
     Structured workflows for maximum efficiency

  • Audit-proof compliance
     Audit audit security thanks to complete documentation and audit trail
  • Made in Germany
    Maximum security and quality with local contacts.

Why BAYOOSOFT Themis Is Really Worth It

Save effort, avoid risks and keep your documentation under control – digital, traceable and audit-proof.

Continuous development since 1998

BAYOOSOFT Themis (formerly BAYOOSOFT Riskmanager) has been continuously developed since its inception in 1998. In addition to updating the software solution—as part of a software update agreement—new extension modules and usability optimizations are also incorporated into the ongoing development:

1998: Risk 1.0 – the foundation stone:
Risk 1.0 is the predecessor of Qware® Riskmanager. It is the first and only software solution on the market that complies with the EN 1441 standard, which came into force in 1999.


1999: BAYOOSOFT Risk Manager is launched—a new development in accordance with EN ISO 14971:2000:
Just two years later, a completely new version was developed based on the experience gained from the first customer projects, which, in addition to new technology and numerous functional enhancements, primarily covered the successor standard EN ISO 14971:2000. This version bore the name Qware® Riskmanager for the first time and was developed as a database-supported multi-user application.

1998: Risk 1.0 – the foundation stone:
Risk 1.0 is the predecessor of Qware® Riskmanager. It is the first and only software solution on the market that complies with the EN 1441 standard, which came into force in 1999.

1999: BAYOOSOFT Risk Manager is launched—a new development in accordance with EN ISO 14971:2000:
Just two years later, a completely new version was developed based on the experience gained from the first customer projects, which, in addition to new technology and numerous functional enhancements, primarily covered the successor standard EN ISO 14971:2000. This version bore the name Qware® Riskmanager for the first time and was developed as a database-supported multi-user application.

Versions 2.0 – 3.1.2 – continuous improvement:
Qware® Riskmanager, the software for risk management according to DIN EN ISO 14971, is continuously improved and expanded. Changes to the standard and customer requests are taken into account in order to provide you with an optimal working tool.

Users are pleased with the improved template management and the automatic spell checker. The implementation of the knowledge database enables the use of data from already closed files. The consistently improved user interface of the software ensures intuitive user guidance and quick familiarization of new employees.

2011: Versions 4.0 – 4.2.5 – Qware® Riskmanager gets a new look:
After 12 years of continuous development, Qware® Riskmanager gets a new user interface and now supports the database model under Microsoft SQL Server. Users can look forward to the first usability management extension module that is fully integrated into the risk management process. The new Advanced Reporting module enables the free design of printouts.
FMEA is also offered as an additional method for risk analysis and is celebrated by many customers.

2012: Versions 4.5-4.6 – The powerful knowledge database:
The CSV import into the knowledge database enables easy maintenance of existing data in Risk Manager and therefore a quick start to working with the software. Users now have the option of mapping risk analysis for products, components and processes with Qware® Risk Manager, which also gives hospitals and clinics access.

2012: Version 4.6.1 – Adaptation to ISO 14971:2012:
Even before ISO 14971:2012 comes into force, Qware® Riskmanager will be adapted to the changes: Users can perform a risk/benefit analysis for each individual risk in accordance with the standard. A note on the ALARP area has been introduced in the graph definition area. It is also possible to edit the ALARP area, which according to ISO 14971:2012 may no longer be used for economic reasons. With this change, the ALARP area in Qware® Riskmanager can be edited, renamed or deleted.
Another feature of this version is the auto-complete function of the knowledge database, which allows users to reuse their knowledge from old files even more quickly and efficiently.

2013: Versions 5.0–5.4—Qware® Riskmanager provides an overview and highlights errors:
The path toward comprehensive technical documentation for medical devices continues to gain momentum starting with Version 5, thanks to two additional extension modules. This year, Qware® Riskmanager is expanding with Medical Electrical Equipment Module for creating the conformity report in accordance with 60601-1, 3rd edition, as well as Essential Requirements – Module compliant with the IVDD 98/79/EC and MDD 93/42/EEC (2007/47/EC) directives. Through their full integration into the risk management process, both modules enable rapid and secure documentation and result in significant time savings for users.

Another feature that makes daily work easier for Qware® Riskmanager users is the set of dashboards for all modules. These dashboards display the current status of projects and highlight potential inconsistencies and errors.

2014: Version 6 – Efficient Management of Product Requirements in Qware® Riskmanager:
With the extension module Requirements Engineering , product requirements can be created and linked to the Usabilityand Risk Management be linked. The Requirements Engineering module dashboard shows users which requirements currently lack validation, verification, and functional coverage. It also provides an overview of functions and actions that are not assigned to any requirement.

2014: Version 7 – New Core Features: Compliance with 21 CFR Part 11:
The new core features—audit trail, digital signature, and password complexity—enable compliance with 21 CFR Part 11 when creating the risk management file. When the audit trail is enabled, all changes that users make to data in Qware® Riskmanager are recorded. The digitally signed documents make it even easier for users to create technical documentation that complies with FDA requirements.

2015: Version 8 – Medical IT Networks in Accordance with EN 80001-1:
With the release of Version 8, users can perform risk management for medical IT networks in accordance with EN 80001-1 in Qware® Riskmanager.

2016: Versions 8.1–8.6—Usability improvements and compliance with the requirements of IEC 60601-1:
The module Medical Electrical Equipment is receiving an update to support the requirements of IEC 60601-1, including the new version of the standard. Further usability enhancements to the Qware® RiskManager—such as performance improvements, templates for risk graphs from completed projects, and other customer-specific requests—have been implemented. Additionally, compatibility with Windows 10 has been established.

2018: Version 9—Addition of a medical device classification system and a new design:
Version 9 of Qware® Riskmanager features a new, modern design. The existing module for ensuring fitness for use has been updated in accordance with DIN EN 62366:2017-07. As part of these updates, formative and summative evaluations can now be incorporated. The Medical Devices Regulation is also now being integrated into the system. A medical device classifier helps determine the risk class by asking simple questions. The Essential Requirements This module now covers the basic performance and safety requirements of the MDR and IVDR.

2019: Requirements traceability and an installable technical interface expand the feature set in Version 9.1:
In addition to tracking requirements from actions to functions, Qware® Riskmanager now offers in the Requirements Engineering It now also offers the ability to link requirements across different document types and generates a corresponding traceability matrix at the click of a button. At the same time, for custom-configured technical implementations, a separately installable Programming Interface provided as an extension module.

2019: Qware® Riskmanager becomes BAYOOSOFT Risk Manager:
Not only is Riskmanager expanding its range of features—BAYOONET AG, the manufacturer, is also steadily expanding its portfolio. In addition to BAYOOMED and other business units, the software solutions Fileserver Management Suite and Qware® Riskmanager are now offered as BAYOOSOFT Access Manager and BAYOOSOFT Risk Manager under the BAYOOSOFT – Management Software division.

2020: New module: Machinery Directive:
A new extension module is now available to support the testing of essential requirements for machinery in accordance with Directive 2006/42/EC. Similar to the functionality of the Essential Requirements module, a checklist filter makes it possible to narrow down the questions to be answered. At the same time, the answers to the questions are fully integrated into risk management by linking hazards or measures, for example.

2021: Software Lifecycle Processes According to IEC 62304:
With the extension modules Requirements Engineering and REST API in combination with risk management in accordance with ISO 14971, BAYOOSOFT Risk Manager now offers a solution for creating technical documentation that complies with IEC 62304.

2021: Version 10.3—Implementation of new features and enhancements, as well as an update to the system requirements:
Version 10.3 of BAYOOSOFT Risk Manager introduced additional planning functions for post-market surveillance. In addition, functional coverage in requirements engineering was established through interfaces in the form of the REST API. With the update to the system requirements, SQL Server version 2017 and Microsoft .NET Framework version 4.8 are now recommended for running BAYOOSOFT Risk Manager.
2021: Version 10.4—Implementation of new features and enhancements, as well as an update to the system requirements:
With version 10.4 of BAYOOSOFT Risk Manager, users can take advantage of new features such as the classifier for IVDs (in vitro diagnostic devices) to determine risk classes A through D. In addition, enhancements in the areas of risk analysis, risk assessment, action management, and residual risk assessment complement the software solution. With the update to the system requirements, SQL Server 2017, Microsoft .NET Framework version 4.8, and Microsoft Windows 8 are now recommended for running the BAYOOSOFT Risk Manager.
2022: Version 10.5 – Implementation of New Features and Enhancements:
With version 10.5 of BAYOOSOFT Risk Manager, users can take advantage of new features such as the automated import of unstructured risk management files. Furthermore, it is now possible to add new elements of the analysis tree directly to the knowledge base and to visualize existing traces between elements. In addition, the enhancements “Advanced Template Management” for the entire Risk Manager and the “Multi-User Function” for the entire “Clinical Assessment” module are now available.

2023: BAYOOSOFT Themis Documentation Guide:
With BAYOOSOFT Themis opens a new chapter in technical documentation. As the first available module, the Documentation Guide is part of the next generation of systems for validated solutions relating to documentation processes for medical devices and in-vitro diagnostics. It offers all the basic functions of the Risk Manager, but can be installed as a desktop app or used in the web interface regardless of location and device.

2023: BAYOOSOFT Themis 2023.4 – Expansion of the GSPR Checklist for MDSAP Countries
The General Safety and Performance Requirements of the MDR and IVDR have been expanded to include the requirements of MDSAP countries. It is now possible to conduct a joint conformity assessment for multiple target markets.

2024: Digital Management of QM/ISM Processes
With its proven task-based approach and comprehensive versioning concept, BAYOOSOFT Themis can now also support the creation and management of quality and management systems. Additional documentation guides for ISO 13485, ISO 27001, and ISO 9001 enable transparent traceability of standard requirements to implemented SOPs, work instructions, and role descriptions for responsible parties.

2025: Impact Analysis & Combining PHA & FMEA
With the FMEA method now also implemented in BAYOOSOFT Themis, product risk analysis can be directly linked to system FMEA, design FMEA, and process FMEA. This allows hazards to be examined more thoroughly, resulting in a comprehensive risk management system. Supplemented by the impact analysis—which highlights dependencies for review whenever a change is made—this significantly simplifies working with the documents.

Quality and Security Confirmed: BAYOOSOFT is ISO 9001-certified and has successfully completed a TISAX assessment.

BAYOOSOFT ist TISAX geprueft

Real Voices, Real Opinions: Customer Reviews in the Spotlight

BAYOOSOFT Themis - Unsere Kunden im Ueberblick
Dr. Jan Ole Jungmann

EUROIMMUN Medizinische Labordiagnostika AG

“We used to work with Excel spreadsheets, and things could easily get lost in the shuffle. Our alternative ALM software solutions were very generic and not much better than the Excel spreadsheets. With BAYOOSOFT Themis, we don’t have to worry, since well-maintained documentation is generated entirely at the click of a button.”

BAYOOSOFT - Unsere Zufriedenen Kunden

Svenja Winkler
CEO

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