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.