avaRIMx
Your RIMS for MedTech & IVD
With avaRIMx, avasis is launching a RIMS (Regulatory Information Management System) that has been specially developed for the requirements of medical technology and in vitro diagnostics companies. Utilizing avaRIMx, manufacturers can easily manage regulatory information, product approvals, and deadlines in a centralized, transparent manner and keep them up to date throughout the entire product life cycle.
At the same time, avaRIMx provides full transparency across your entire portfolio. At a glance, a central dashboard visualizes for each product approval status, version and market. Changes, responsibilities, and processes are clearly traceable. Reporting and compliance documentation can be created quickly and securely. Decisions are no longer based on scattered Excel lists, but on consistent and traceable data.
- All markets, products, and global approvals in an overview
- Full transparency and control of status, content, and deadlines
- Seamless end-to-end data and process consistency from a single source
- Structured and easily customizable workflows for your processes
- Reports and analyses everyone can understand in a clear and crisp manner
Submission management enables the central administration of all product market authorization is enabled by submission management. It links product versions and/or product groups with associated approvals and current status including the belonging technical documenation.
Your benefits
- Overview of approval status per product, product version, and/or product group and market
- Control and tracking of ongoing approval steps
- Automatic reminders for for upcoming expiring approvals to ensure renewals on time
- Standardized processes and tasks with templates
Supporting companies in the systematic planning and control of product discontinuation with build in product phase-out management. Including a central overview of all affected products, the respective markets, and the timing of the phase-out process.
Your benefits
- Transparent management of phase-out plans per product/product version and market
- Task tracking and responsibilities during the discontinuation process
- Support for standardized procedures through templates that simplify recurring phase-out processes
avaRIMx's Product Portfolio Insights & Analytics provides data-driven key-insights into your entire product portfolio. It enables you to analyze product versions/groups, approval status, phase-out processes, and markets for making informed decisions.
Your benefits
- Structured dashboards and reports with product status and approvals
- Visualized also in a world map showing which product has which version in which market and which approval status, with filter options directly on the map
- Highlighting “Recent Submissions” for quick tracking
- Support for strategic decisions through data-based insights
Combine avaRIMx with your existing Siemens Teamcenter with Medical Device Solution or use it as a standalone solution.
avaRIMx’s key feature is its native integration with Siemens Teamcenter and the Teamcenter Medical Device Solution by avasis. Product master data and technical documentation remain in existing PLM system (Product Lifecycle Management System) and are linked in avaRIMx. This means the single-source-of-truth approach is kept by continuous collaboration between Regulatory Affairs and Research & Development based on the existing system landscape.
As a standalone solution, avaRIMx is deliberately designed to blend into existing authoring and PLM systems and can be integrated with different environments. Technical documentation continues to be created and maintained in the designated systems, while avaRIMx establishes regulatory control and creates transparency. This approach reduces complexity, avoids redundant data storage, and facilitates the introduction of the solution in any business domain.
We offer our own best practice configuration packages for Teamcenter Medical Device Solutions based on the technical expertise of the avasis team and the wide range of experience in various projects.
Our experts are happy to help you. We assist you in finding the optimal PLM solution.
