DE 
Themis Documentation Guide [Hosted]
€33.32
€28.00
In stock
Product.Nr.
BYS-TH-DG-H
Your Way to Technical Documentation
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 Guideline for Technical Documentation
✓ Which documents have to be submitted for approval to the Notified Body?
✓ What is the current status of the information supplied?
✓ Who is currently working on it, and what do you still need to release?
Achieve transparency and get a comprehensive overview with Themis Documentation Guide.
Teamwork
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.
Digitization
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.
Compliance
In conformity with MDR & IVDR
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 "Authorization Fee for Payment Method" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.
| Cloud hosted | On premise | |
| Fulfilled Regulatory Requirements |
MDR 2017/745 IVDR 2017/746 |
MDR 2017/745 IVDR 2017/746 |
| Document Management | ✓ | ✓ |
| Traceability | ✓ | ✓ |
| Generation of Technical Documentation Files including folder structure | ✓ | ✓ |
| Team Collaboration Capabilities | ✓ | ✓ |
| Versioning & Approval Workflow | ✓ | ✓ |
| Audit Trail & Version History | ✓ | ✓ |
| Validated according to ISO 13485 | Environment is validated by manufacturer |
Prepared validation document forms will be provided |
| Technical Support | ✓ | ✓ |
| Optional Services | 30 days free trial period* User Training |
30 days free trial period* Installation support User Training Validation Services |
* The product "Authorization Fee for Payment Method" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.
Themis Documentation 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 "Authorization Fee for Payment Method" is added to your shopping cart and we charge a fee of €0.50 (excl. VAT) for this.