Capture, Investigate, and Resolve Every Complaint with Confidence.
Connected Complaint Management Across the Quality Lifecycle
OneQMS Customer Complaint Management Software helps pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations manage customer complaints through a structured, controlled, and traceable process. From complaint intake and classification to investigation, assessment, resolution, and closure, every complaint is managed within a single connected workflow.
Each Customer Complaint record captures the information required to manage the complaint effectively, including complaint details, product and customer information, initial assessment, investigation findings, supporting evidence, correspondence, actions, approvals, and final resolution. Defined workflows and configurable processes help teams ensure that complaints are consistently assessed, investigated, and addressed within established timelines.
OneQMS connects Customer Complaints with related CAPAs, Deviations, Change Controls, Audit Findings, Documents, Training, OOS, OOT, Incidents, and Quality Events, providing visibility across related quality activities. Automated notifications, task assignments, due date tracking, escalations, and approval workflows help teams coordinate complaint investigations and ensure appropriate follow-up without losing traceability.
Built for organizations operating under GMP, GxP, FDA 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 requirements, OneQMS enables quality, regulatory, customer service, manufacturing, and operations teams to manage complaint records within controlled workflows while maintaining data integrity, traceability, and inspection readiness.
Whether you are looking for Customer Complaint Management Software, Complaint Handling Software, Complaint Tracking Software, Pharmaceutical Complaint Management Software, Medical Device Complaint Management Software, or an integrated eQMS, OneQMS provides a secure, cloud-based platform that standardizes complaint handling, improves investigation visibility, strengthens quality oversight, and supports timely resolution.
Key Capabilities
Centralized Complaint Intake
Capture customer complaints in a structured format and maintain the relevant customer, product, and event information within a single controlled record.
Consistent Complaint Assessment
Standardize the initial evaluation and classification of complaints to help teams determine the appropriate investigation, priority, and follow-up activities.
Structured Complaint Investigation
Provide investigators with a controlled environment to document evidence, findings, correspondence, analysis, and conclusions, creating a consistent record for every complaint.
Connected Quality Management
Link complaints with related quality records such as CAPAs, Deviations, Change Controls, OOS, OOT, and other quality events, helping teams identify relationships between customer feedback and broader quality issues.
Timely Resolution and Escalation
Track investigation activities, responsibilities, and deadlines while using automated notifications and escalations to help prevent critical complaint activities from being overlooked.
Regulatory Compliance & Inspection Readiness
Maintain complete complaint histories, investigation records, actions, approvals, and audit trails to support GMP, GxP, FDA 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 requirements while facilitating efficient retrieval during audits and inspections.
Key Features
Complaint Lifecycle Management
Manage complaints from initial intake and assessment through investigation, resolution, review, and closure.
Complaint Intake and Classification
Capture complaint information and categorize complaints using defined criteria for consistent assessment.
Product and Customer Information
Maintain relevant product, customer, batch, and complaint details within a centralized record.
Investigation Management
Document investigation activities, evidence, findings, correspondence, and conclusions throughout the complaint lifecycle.
Root Cause Analysis
Identify underlying causes and contributing factors associated with customer complaints.
Action Management
Assign and track activities resulting from complaint investigations with clear ownership and target dates.
Quality Record Linkage
Connect complaints with CAPAs, Deviations, Change Controls, Audit Findings, OOS, OOT, Incidents, Documents, Training, and Quality Events.
Notifications and Escalations
Automatically notify responsible users and escalate approaching or overdue complaint activities.
Electronic Review and Approval
Route complaint records and investigation outcomes through configurable review and approval workflows.
Complete Complaint History
Maintain correspondence, investigation records, decisions, actions, reviews, and approvals in a traceable history.