Complaint Handling

Resolve issues faster and stay audit-ready with customer cases, complaint investigations, and FDA reporting connected on a unified product thread.

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Speedy Complaint Resolution Secures Customer Trust
What is Complaint Handling?
Complaint handling is the structured process by which manufacturers receive, investigate, evaluate, and resolve reported product issues from customers or the field. Propel connects complaint handling directly to the product record, so modern manufacturers can protect product safety, strengthen compliance posture, and defend brand trust.
Regulatory Reporting Discipline
Getting agency reportability wrong or late carries significant regulatory consequences. In-line decision trees and electronic forms ensure accurate, timely submissions to protect patients, customers, and the business simultaneously.
End-to-End Complaint Traceability
When complaint records connect directly to affected items and BOMs, as well as tie to NCMRs and CAPAs, quality teams can trace root cause with precision and close the loop before similar issues recur in the field.
Cross-Functional Complaint Intake
A seamless handoff between customer service and quality teams—from customer case to formal complaint record—is the foundation of a fast, defensible process.

Propel Closes the Loop from Complaint to Resolution

Automated Complaint Intake
Propel automatically propagates customer cases into Complaint records via configured mapping, eliminating errors and double-entry between customer service and quality. The product thread stays continuous from first report through final disposition, with no manual handoff required.
One-Click FDA Submissions
Propel completes MedWatch Form 3500A from existing case and quality data, and one button submits it digitally via AS2 protocol to the FDA. Built-in decision trees determine reportability and timelines automatically, and e-submissions capture all acknowledgements for airtight audit traceability.
Connected Investigation and CAPA
When a complaint warrants corrective action, Propel connects it directly to CAPA, NCMR, BOM data, and supplier workflows. Teams trace field issues down to specific components, notify procurement, and drive resolution from a single platform without switching systems.
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You already have the product data. See what becomes possible when it's all connected.
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More Capabilities
Decision Trees for Reportability
NCMR Management
Supplier Management and SCAR
Document and Change Control
Training Management
Decision Trees for Reportability
Pre-built decision trees evaluate event severity and automatically determine global regulatory reporting requirements, ensuring consistent, defensible reportability decisions and reducing the risk of missed or late submissions.
NCMR Management
Non-Conforming Material Reports capture defective product and supplier data in direct connection to complaint records, CAPAs, and audits. Integrated workflows enable rapid dispositioning and resolution in compliance with FDA and ISO regulations.
Supplier Management and SCAR
Complaint-driven corrective actions extend to suppliers through automated Supplier Corrective Action Requests. Quality teams can escalate field issues directly to the supply chain and track supplier responses without leaving the platform.
Document and Change Control
When complaints trigger design, process, or procedure updates, Propel manages a full change control workflow with real-time redlines, contextual collaboration, and automated approval routing, keeping documentation current and audit-ready.
Training Management
Updated complaint-handling SOPs automatically trigger training plans tied to the revised document version. Role-based assignments, AI-generated quizzes, and compliance reporting ensure every affected team member is trained and that evidence is captured for regulators.
Concept To Customer Solutions for Fast-Moving Product Companies
Propel QMS
Complete quality management system that unifies part, process, and supplier quality to deliver safer products, higher customer satisfaction, and increased profits.
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Propel One
Natively integrated agentic AI automates workflows, surfaces insights, and accelerates every team across PLM, QMS, and PIM from concept to customer.
how it works
Supplier Community
Secure partner management extends quality workflows, BOM collaboration, and supplier onboarding across your value chain so you launch better products faster.
how it works
ASP Cut Complaint Resolution Time by 45 Days
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Replacing 6 quality systems with 1
Advanced Sterilization Products (ASP) replaced six quality applications with one Propel platform, eliminating double-keyed data between customer service and quality. With Digital FDA Submissions, their team now reports MedWatch 3500A forms electronically from existing case data, with full audit traceability and no manual rework.
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FAQ
How does Propel eliminate double-entry between customer service and quality teams?
Propel's Case-to-Complaint capability uses configured mapping to automatically convert cases into formal complaint records. The handoff happens without manual data entry, preserving all original case data on the same unified product thread. Customer service and quality teams work from one connected record from first report through final resolution.
Can Propel handle FDA eMDR submissions directly from within the platform?
Yes. Propel completes MedWatch Form 3500A using much of the existing case and quality data, then the user hits the submit button to digitally send AS2 to the FDA. All Acknowledgements and proof of submission are automatically captured, creating a complete audit trail without switching systems or re-entering data in a separate web-based submission tool.
How does Propel help teams determine which complaints require regulatory reporting?
Built-in decision trees evaluate event severity and apply global regulatory criteria to automatically determine reporting requirements and applicable timelines. This removes the guesswork from reportability decisions, reduces the risk of non-compliance, and ensures consistent outcomes across every complaint record, regardless of which team member processes the case.

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