A certified QM/ISM system demonstrates to customers and regulatory authorities that an organization takes the necessary steps to ensure that the developed products are safe and effective. Implementing such a system enhances efficiency and minimizes the risks of recalls and liability claims.
BAYOOSOFT Themis is your validated solution for the documentation processes of quality and information security management systems. By digitizing related processes, you sustainably reduce the effort required for documentation and minimize redundant data.
A management system is a structured framework that helps organizations organize, manage, and continuously improve their business processes.
Key Features include:
These systems improve efficiency, create competitive advantages, and ensure compliance with legal regulations. The Management Systems Pack enables you to create, maintain, and continuously improve these components in the form of an integrated management system. By combining it with the following guides, you can leverage the synergies of multiple standards and simplify administration:
Collaboration Rethought
Thanks to multi-user capability, colleagues can simultaneously capture content and results in the same document and are guided through the process in a structured manner. The use of task labelling and assignment (for open and processed tasks), team dashboards, notifications, as well as chats and comments, enables easy and fast communication within the team – even across multiple locations.
A Centralized Data Pool
In a clearly structured environment, all relevant information is gathered and dynamically linked with each other in a fine-granular manner. The knowledgebase also generates cross-project synergies and enables you to use the generated know-how throughout the organization. The creation of a knowledge platform as well as structured templates facilitates the efficient and secure performance of documentation processes.
Conforming to Standards
The approval of your product by notified bodies largely depends on compliance with the required guidelines, standards, and regulations.
Our software solution creates complete and compliant technical documentation from your data and efficiently guides your team through all necessary processes, even if team members have no prior experience.
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).
For the downloadable version (on-premise installation), please contact our sales department at: [email protected]
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Cloud hosted / Software as a Service |
Modules included in the package |
Management Systems:
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Document Management |
✓ |
Traceability |
✓ |
Generation of Documentation |
✓ |
Team Collaboration Capabilities |
✓ |
Versioning & Approval Workflow |
✓ |
Audit Trail & Version History |
✓ |
Validated according to ISO 13485 |
Environment is validated by manufacturer |
Technical Support |
✓ |
Optional Services |
30-Day Free Trial Period* |
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).
The licensing of the Themis Management Systems is done in the form of Named-User licenses, which can be assigned directly by the system administration in the software solution after purchase. The minimum order quantity is three Named-User licenses.
Licenses are available on a subscription basis with monthly or annual terms, with the first month offered as a free trial period.
* The product "Authorization Fee for Payment Method" will be added to your shopping cart, with a fee of €0.50 (excluding VAT).