Efficient quality and ISMS software for maximum security
With BAYOOSOFT Themis Management Software, we offer you a comprehensive solution for quality management (QM) and information security management (ISMS). A certified QM/ISMS is important proof to customers and regulatory authorities that your company is taking all the necessary steps to ensure the security 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
BAYOOSOFT Themis offers a validated solution for the documentation processes in quality management systems (QMS) and information security management systems (ISMS). By digitizing your processes, you reduce the documentation effort in the long term and minimize redundant data. A management system is a structured framework that supports your company in organizing, controlling and continuously improving 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 increases 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 have to 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 have to release?
You ask yourself questions like these every day? Gain transparency and get an overview with the Themis Documentation Guide.
New requirements
As regulatory requirements continue to rise, the world of work is becoming increasingly volatile. Topics such as collaboration, growing teams and working across locations are now commonplace in the world of medical device manufacturers.
Rethinking technical documentation
This is precisely why BAYOOSOFT Themis is reshaping the path of technical documentation – holistically, innovatively, individually and globally.
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 records all relevant information in a structured manner, stores it in an audit-proof manner and links it dynamically. You can base your risk management on FMEA or PHA. Integrated project and version management, action management, risk inventory with automatic reminders and self-learning template management make the process much easier and faster.
Standard-compliant
BAYOOSOFT Themis is the world’s leading software for the creation of risk management files according to ISO 14971 and fulfills 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 tried-and-tested structure, it guides you through all the necessary steps up to the usability engineering file in accordance with DIN EN 62366 and IEC EN 60601-1-6. This includes the definition of usage conditions, user groups, usage scenarios, validation plans and verification methods such as usability tests and expert reviews. This covers all the requirements of the standards and significantly speeds up work processes.
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. Measures automatically become new requirements, traceability is ensured across different documents, and requirements are validated and verified. Usability-relevant requirements are integrated into the usability engineering process, avoiding duplicate data entry.
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