REMETREX PQMS was designed around the complaint lifecycle. The system gives Quality teams a structured foundation for managing complaint information, investigations, reportability evaluations, trending, and closure.

General-purpose quality platforms can be configured to handle complaints, but complaint management has its own data, workflow, investigation, reportability, and trending requirements. REMETREX PQMS starts with those requirements at the center.

Intake → Triage → Investigation → Regulatory Evaluation → Trending → Closure. The system connects these stages so teams can manage the complaint as a complete record rather than a collection of disconnected activities.

Capture complaint information in a structured record designed around the information Quality teams need to evaluate the complaint and determine the appropriate next steps.  API connectivity allows case initiation in your CRM to feed to Remetrex PQMS with initial and follow-up information.

Support consistent classification, prioritization, assignment, escalation, and routing according to the organization’s defined processes and business rules.

Maintain a structured investigation record tied to the complaint, including relevant product or device information, findings, related activities, and applicable linkages to other quality records.  Shared investigations such as Record Review (batch record reviews), retain samples and other types are entered once and link to cases for a product and lot.

Link lot together to provide consistency on trending to include lots that are related to the same bulk/semi-finished lot for more accurate trending.

Trending includes calculated upper control limits to flag lots that have surpassed the limit for the indicated category of quality defect.   This is used to identify recurring issues that surpass the calculated limit.   Once the UCL is surpassed additional investigations are needed.  But until it is surpassed, a lighter burden of investigation is needed saving valuable resources.

Support the organization’s process for evaluating and documenting reportability decisions. The system provides a structured place for the decision and its supporting record.

Organize complaint information so Quality teams can evaluate patterns across products, complaint types, geographies, time periods, failure modes, and other relevant dimensions.

Maintain visibility through the complete complaint lifecycle, with a history of actions and a structured closure process.

The system can be adapted within the applicable technical and licensing boundaries to reflect organizational workflows, terminology, data requirements, integrations, and reporting needs.