Does MDARIX replace our QMS or complaint software?
No. MDARIX works beside your QMS or complaint software. Your QMS keeps the complaint record, CAPA and change control.
What stays in your QMS
Complaints are logged and closed in your QMS or complaint software, and CAPA and change control run there. MDARIX never changes your records in it.
What MDARIX adds
MDARIX helps you find signals early, decide with evidence and prove each decision. A person always decides, and people submit every report.
How your data gets in
In the free trial you upload CSV or Excel exports of your complaints, products and lots. In a pilot, your systems are connected through an approved mapping file and refreshed on a schedule.
What MDARIX does
- Opens a signal when complaints about the same problem cluster, and compares each product version's complaint rate with its own history.
- Brings complaints closed as inquiries or no fault found back for a second look.
- Keeps each complaint's reporting clock, and each reportability decision with the named person who made it and their reason.
- Keeps each decision with its evidence and the named person who signed it.
- MDARIX never decides for you and never submits a report: you file every report in the authority's own system.