avaRegulatory
Efficient management of regulatory information & easy integration into product development
Manufacturers of products in regulated industries have to keep track of a multitude of regulatory documents such as laws, standards or guidelines. The requirements contained therein have to be implemented and conformity with them must be demonstrated.
With avaRegulatory you can manage regulatory documents in a central regulatory library, monitor their validity and provide easy access. Individual documents can be labelled with additional information and categorized. Filter functions help to find relevant documents quickly, e.g. for further use in product development projects. For this purpose, our solution already offers a number of best practice categories, which can be quickly and easily adapted and extended by yourself. Relevant information for the management review can be compiled as input with one click - manual creation of lists is no longer necessary.
Regulatory documents can be broken down to individual regulatory requirements and then integrated into product development. For this purpose, avaRegulatory offers special templates and guidance on how you can document and edit content from individual laws, standards or guidelines in a digital form.
Especially for the medical device and IVD sector, we already offer a template for demonstration of conformity with the General Safety and Performance Requirements ("GSPR") from MDR/IVDR, Annex I. Preconfigured 2- and 3-level traceability reports allow you to easily and transparently demonstrate, how each regulatory requirement has been implemented and what evidence is available to support it.
The standard Polarion functions provide a complete audit trail with which you can document and trace every change.
- Central management and monitoring of regulatory documents
- Best practice categories and filter functions enable fast search for further use
- Creation of templates with individual regulatory requirements, e.g. from a specific standard
- Transparent integration of regulatory documents and requirements into product development
- Template for medical device and IVD manufacturers: Digital demonstration of conformity with the Genera Safety and Performance Requirements from MDR/IVDR, Annex I
Find out more about avaRegulatory in our on-demand webinars.
The digital future of regulatory requirements
In this webinar you get an overview of the new SMART standard format and existing services for the automated import of regulatory information from an external database. Moreover, the potential of AI and Large Language Models (LLM) are discussed. Last but not least, it is demonstrated, how the individual information units of a standard can be evaluated in a digitalized way, followed by efficient integration and traceability in requirements engineering as well as verification and validation documentation.
Digitalization of regulatory processes: How to start and what to consider
In this on-demand webinar, we will use practical examples from our projects to explain which questions you should ask yourself as early as possible, what needs to be decided when selecting a possible software solution, what you need to decide internally BEFORE starting a digitization project, and how you can ensure that, in the end, software is implemented that users are really happy with.
On-Demand Webinar: Regulatory Information Management
This on-demand webinar highlights efficient regulatory information management, integrating data into Polarion with avaREGULATORY, and guiding your company to prepare for upcoming changes through SMART standards.
