Efficient quality and ISMS software for maximum security
With BAYOOSOFT Themis Management Software, you get a comprehensive solution for quality management (QM) and information security management (ISMS). A certified QM/ISMS is important evidence for customers and regulatory authorities that your company is taking all necessary steps to ensure the safety and effectiveness of the products it develops.
Implementing this management software not only increases the efficiency of your processes, but also minimizes risks such as recalls and liability claims. This not only ensures your compliance, but also the trust of your partners and customers.
Optimized management software for quality and information security management systems
Optimized management software for quality and information security management systems
BAYOOSOFT Themis offers a validated solution for documentation processes in quality management systems (QMS) and information security management systems (ISMS). By digitizing your processes, you can sustainably reduce the documentation workload and minimize redundant data. A management system is a structured framework that helps your company organize, control, and continuously improve business processes.
The central components here are
- Definition of roles and their responsibilities
- Defining rules and processes to achieve specific corporate goals
Management software for ISO 27001, ISO 9001 and ISO 13485 compliance
This management software boosts your efficiency, creates competitive advantages, and ensures compliance with legal regulations. With the Management Systems Pack from BAYOOSOFT, you can not only implement these management systems but also continuously improve them.
The software supports you in creating, monitoring and optimizing your management systems by leveraging the synergies between different standards, significantly reducing the administrative burden. This means you can manage complex requirements in one integrated system while maximizing the efficiency of your processes.
Documentation Guide
Which documents must be submitted to the notified body for approval? What is the current status of the information supplied? Who is currently working on it and what do you still need to approve?
Do you ask yourself questions like these every day? Get transparency and an overview with the Themis Documentation Guide.
New requirements
As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Issues such as collaboration, growing teams and cross-location working are now commonplace in the world of medical device manufacturers.
Rethinking technical documentation
That is exactly why BAYOOSOFT Themis is reshaping the future of technical documentation—in a holistic, innovative, customized, and global way.
Risk Manager
Medical devices involve risks and therefore require a high level of protection. Risk management for medical devices and in-vitro diagnostics is prescribed in German, European and American regulations.
The ISO 14971 standard defines a procedure for the identification, assessment and control of risks associated with medical devices. These requirements apply throughout the entire product life cycle.
Automated risk management
BAYOOSOFT Themis collects all relevant information in a structured manner, stores it in an audit-proof format, and links it dynamically. You can base your risk management on FMEA or PHA. Integrated project and version management, action item management, risk inventory with automatic reminders, and a self-learning template management system significantly simplify and accelerate the process.
Standard-compliant
BAYOOSOFT Themis is the world’s leading software for creating risk management dossiers in accordance with ISO 14971. In addition, BAYOOSOFT Themis meets the requirements of FDA 21 CFR Part 11.
Device Validation Manager
The DIN EN 62366 standard obliges manufacturers of medical devices to carry out and document a usability engineering process. This not only fulfills legal requirements, but also becomes an important sales factor, as it reduces the risk of operating errors and increases user acceptance.
BAYOOSOFT Themis fully integrates the usability engineering process into risk management in accordance with ISO 14971. With a proven structure, it guides you through all the necessary steps to create a Usability Engineering File in accordance with DIN EN 62366 and IEC EN 60601-1-6. This includes defining conditions of use, user groups, usage scenarios, validation plans, and verification methods such as usability tests and expert reviews. This ensures that all requirements of the standards are met and significantly streamlines workflows.
Requirements Engineer
Requirements engineering is crucial for the error-free development of complex medical systems, especially in the case of complex product concepts and development based on division of labor. It includes the definition and implementation of processes as well as the traceability of all requirements over the entire product life cycle.
BAYOOSOFT Themis fully integrates requirements engineering into the regulatory process. Actions are automatically converted into new requirements, traceability is ensured across various documents, and the requirements are validated and verified. Usability-related requirements are integrated into the usability engineering process, thereby avoiding duplicate data entry.
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