Capture, Investigate, and Resolve Every Incident with Confidence.
Connected Incident Management Across the Quality Lifecycle
OneQMS Incident Management Software helps pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations capture, assess, investigate, and resolve safety, quality, and operational incidents through a structured and traceable process. From initial reporting and classification to impact assessment, investigation, action management, and closure, every incident is managed within a single connected workflow.
Each Incident record captures the information required to understand and investigate the event, including incident details, date and location, affected areas, initial assessment, impact, investigation findings, root cause, supporting evidence, assigned actions, reviews, approvals, and final resolution. Configurable workflows help teams standardize incident handling while ensuring that critical information, decisions, and responsibilities are documented throughout the incident lifecycle.
OneQMS connects Incidents with related CAPAs, Deviations, Change Controls, Quality Issues, Customer Complaints, Audit Findings, OOS, OOT, Documents, and Training, allowing teams to maintain context across related quality processes. Automated notifications, task assignments, due date tracking, escalations, and approval workflows help teams respond promptly, coordinate investigations, and ensure required actions are completed and documented.
Built for organizations operating under GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements, OneQMS enables quality, manufacturing, laboratory, engineering, environmental health and safety, and operations teams to manage incident records through controlled workflows while maintaining data integrity, traceability, and inspection readiness.
Whether you are looking for Incident Management Software, Incident Reporting Software, Incident Tracking Software, Pharmaceutical Incident Management Software, Quality Incident Management Software, or an integrated eQMS, OneQMS provides a secure, cloud-based platform that standardizes incident reporting and investigation, improves response and accountability, strengthens quality oversight, and supports timely resolution.
Key Capabilities
Centralized Incident Reporting
Capture incidents as soon as they occur and maintain all relevant information in a centralized record. Structured reporting helps teams establish a consistent starting point for assessment and investigation.
Impact and Risk Assessment
Evaluate the significance and potential consequences of an incident to determine the appropriate response, investigation depth, and follow-up activities.
Structured Incident Investigation
Provide investigators with a controlled environment to document evidence, observations, contributing factors, findings, and conclusions, creating a complete record of how each incident was assessed.
Connected Quality Processes
Link incidents with CAPAs, Deviations, Change Controls, Quality Issues, Complaints, Audit Findings, OOS, and OOT when additional quality action is required. This maintains the relationship between the incident and subsequent quality activities.
Action and Resolution Management
Assign responsibilities, establish target dates, and track actions through completion. Automated notifications and escalations help teams maintain momentum and prevent important follow-up activities from being missed.
Compliance & Inspection Readiness
Maintain complete incident records, investigation evidence, decisions, approvals, and audit history to support processes aligned with GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11, while enabling efficient retrieval of incident evidence during audits and inspections.
Key Features
Incident Lifecycle Management
Manage incidents from initial reporting and assessment through investigation, action management, review, and closure.
Incident Reporting
Capture incident details, affected areas, dates, locations, and other relevant information in a structured record.
Impact Assessment
Evaluate the potential impact and significance of an incident to support appropriate investigation and response.
Investigation Management
Document investigation activities, evidence, findings, contributing factors, and conclusions.
Root Cause Analysis
Identify underlying and contributing causes to support effective incident resolution and recurrence prevention.
Action Management
Assign, prioritize, and monitor actions resulting from incident investigations with clear ownership and deadlines.
Quality Process Linkage
Connect incidents with CAPAs, Deviations, Change Controls, Quality Issues, Complaints, Audit Findings, OOS, OOT, Documents, and Training.
Notifications and Escalations
Automatically notify responsible users and escalate approaching or overdue incident activities.
Electronic Reviews and Approvals
Route incident assessments, investigation outcomes, and closure decisions through configurable approval workflows.
Complete Audit Trail
Maintain a detailed history of incident records, changes, investigation activities, decisions, actions, reviews, and approvals.