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.