Comprehensive, innovative, individual and global
While regulatory requirements are constantly increasing, the world of work is becoming more and more volatile. Subjects such as collaboration, expanding teams, and cross-site work set-ups have become more and more part of the daily business of Medical Device Manufacturers.
This is exactly why BAYOOSOFT Themis is redesigning the way of Technical Documentation – holistically, innovatively, individually and globally.
The ISO 27001 Guide covers all the requirements of the ISO standard of the same name and specifies the necessary steps for setting up, implementing, maintaining and continuously improving a documented information security management system (ISMS), taking into account the individual context of your organisation.
The task-based approach ensures that you fulfil all the requirements of your ISMS. In addition to these requirements, the guide contains the information security measures referenced in the appendix so that these can also be integrated into your security strategy.
Collaboration reimagined
Thanks to multi-user capabilities, team members are able to create content and deliverables in parallel in the same file and are guided through the process in a structured manner. By tagging and assigning pending and processed tasks, team dashboards, notifications as well as chats and comments, you can easily and efficiently share information within your team – even across sites.
One central 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.
In conformity to several ISO norms
The approval of your product by the Notified Body will be determined by its conformity with the applicable directives, norms and standards. The software solution generates comprehensive and compliant Technical Documentation based on your data and guides your team efficiently through all the necessary processes – even for inexperienced colleagues.
* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.
For a download version (installation on premise), please contact our sales department: [email protected]
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Cloud Hosted / Software as a Service |
Modules included in the package |
ISO 27001 |
Document Management |
✓ |
Traceability |
✓ |
Generation of requirements and specification documents for each target country |
✓ |
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 days free trial period* |
* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.
Themis ISO 27001 Guide is licensed in the form of named user licenses, which can be assigned directly in the software solution by the system administrator after purchase. The minimum purchase quantity is three named users.
Licenses can be purchased in the form of a subscription model with a monthly or annual term. The first month is a free trial period.
* The product "Payment method authorisation fee" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.