Complaint handling management software manages complaint handling in compliance with FDA guidelines. It records all complaints reported by customers and/or consumers to investigate the problems, keeps records of these complaints including information about the customers and the products. Complaint handling software also provides an electronic form, for Electronic Medical Device Reporting (eMDR).
Through our comprehensive complaint tracking software module, organizations are able to investigate any incoming customer or regulatory complaints, keep records and track these complaints including information about the customers, suppliers and the products in order to identify, mitigate and prevent recurrence of common complaint types. The complaint handling module is able to incorporate risk management tools to quantify the risk of the complaint being tracked, and immediately generate a Corrective Action (CAPA) from the complaint record, inheriting all relevant complaint data.
EtQ Reliance complaint handling software module is integrated with the electronic submission gateway for medical device reporting, and can generate eMDRs directly from the Complaint record, and automatically submit this data to the FDA.