Closed-Loop Process for Managing Customer Complaints and Regulatory Reporting
Quality Management for Life Sciences manages complaints and non-conformance reports (NCRs) within an organization in an effective, consolidated, global approach. It provides a best practice process for managing customer complaints and regulatory reporting; managing the entire lifecycle of the event from intake, investigation, root cause analysis and reporting to regulatory agencies (Adverse Event Reporting); including electronic reporting. It also provides a company with a global, integrated closed-loop system for corrective and preventative action (CAPA) tracking of production and non-production quality issues and audit management for follow-up.
Quality Management for Life Sciences is available on premise.
Key Features and Benefits:
Efficiently processes complaints across operations from intake though investigation, reporting assessment, root cause analysis, corrective action and regulatory reporting—all in a compliant, closed-loop workflow
Easily create and capture all needed information for each event
Quick view and traceable workflow for a closed-loop system
Easily define and execute the disposition of production material associated with a product
iConvert a complaint to an inquiry or Equipment Service Request, or back to a complaint
Comprehensive control, review, and disposition process to govern questionable products by defining Product Control Records (PCRs).
Multiple PCRs can be created to capture separate disposition approaches. Tracking all returns until completion.