Track, manage, investigate, and close every Corrective and Preventive Action with confidence.
Connected Quality Across the Lifecycle
OneQMS CAPA Management Software helps pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations manage the complete CAPA lifecycle from initiation and investigation to action implementation, effectiveness verification, approval, and closure.
Every CAPA can be linked to its originating quality event, including Deviations, Customer Complaints, Audit Findings, OOS, OOT, Incidents, Quality Events, and Change Controls. This connected approach provides complete context, reduces duplicate data entry, and enables end-to-end traceability across the quality management process.
With structured root cause analysis, configurable workflows, automated task assignments, due date tracking, notifications, escalations, electronic approvals, and comprehensive audit trails, OneQMS helps quality teams improve accountability, strengthen investigations, and maintain continuous inspection readiness.
Key Capabilities
Connected Quality Management
Link CAPAs directly to the quality events that initiated them, providing complete visibility and traceability throughout the investigation and resolution process.
Structured Investigation
Standardize CAPA investigations with defined workflows and structured root cause analysis to support consistent and effective problem resolution.
Workflow & Accountability
Automate assignments, reviews, approvals, deadlines, and escalations while maintaining clear ownership at every stage of the CAPA lifecycle.
Effectiveness Management
Track and document effectiveness checks to confirm that corrective and preventive actions have addressed the underlying issue and reduced recurrence risk.
Regulatory Compliance
Support quality processes aligned with Good Manufacturing Practice, Good Practice requirements, FDA 21 CFR Part 11, and EU Annex 11.
Inspection Readiness
Maintain complete records, approvals, traceability, and audit history to help quality teams quickly retrieve reliable evidence during regulatory inspections.
Key Features
End-to-End CAPA Lifecycle Management
Manage CAPAs from initiation and investigation through action implementation, effectiveness verification, and closure.
Quality Event Linkage
Connect CAPAs with Deviations, Customer Complaints, Audit Findings, OOS, OOT, Incidents, Quality Events, and Change Controls.
Root Cause Analysis
Conduct structured investigations to identify and address the underlying causes of quality issues.
Corrective & Preventive Actions
Define, assign, track, and manage corrective and preventive actions with clear ownership.
Configurable Workflows
Configure review, approval, assignment, and closure workflows according to organizational requirements.
Task & Due Date Management
Track action items, responsibilities, priorities, and deadlines throughout the CAPA lifecycle.
Notifications & Escalations
Keep stakeholders informed and automatically escalate approaching or overdue actions.
Effectiveness Verification
Document and verify whether implemented actions have effectively addressed the identified issue.
Electronic Approvals
Enable controlled electronic review and approval of CAPA records.
Complete Audit Trail
Maintain a detailed history of changes, decisions, actions, reviews, and approvals.