QMS Risk Reporting
After each hazard or risk steps, one qms event is generated and sent to the QMS manager, that can enforce document approval workflows by category.
One system/Statistics for all hazards
All the hazardous situations, categories, harms and statistics are on a single interface, graphically mapped out for a simple overview.
ISO 14971 Templates
Each Risk is defined by a template based on ISO 14971 Standard, that can be modified and tailored to your company needs.
CAPA process can be dropped into the project, thereby triggering a special sequence of events required to resolve the QMS issue.
Focuses on uncovering and describing as many of the potential risks associated with the application of your device as possible.
Gives the clear view of the desired outcome of the CAPA in use, including comprehensive review of issues regarding human resource, equipment, management, product design, material, manufacturing processes etc.
CAPA Follow Up
A CAPA can be traced back to its origins, yet is reported through the QMS process. Resolution with a signed document, electronic or otherwise, now has a date stamped electronic trail, that, if required, can be printed.
All your RM files available
keeps your RMF documents readily available to update with production and post-production information-so you don’t need to reinvent the wheel.
Focuses on comparing your risk analysis results with your organization’s predetermined risk threshold.
Build a database by collecting production and post-production information throughout your product’s lifecycle. With the complete summary of the hazard analysis by its details, it’s easy to find the underlying issue of the problem.
Put in place controls to prevent or mitigate an undesired event and leverage those controls to reduce risks before they happen
Every project can have different risk categories with unique CAPA ID’s, that helps to make every CAPA record unequally identified and administered for effective follow-up.