VaultGXP is your all-in-one Digital Pharma Solution
LABORATORY INCIDENT
A laboratory incident is an unplanned or unexpected event in a laboratory setting that can compromise safety, product quality, data integrity, or regulatory compliance. These incidents can range from minor issues to serious accidents with potential for significant consequences.
- Capture Events Early-Respond Effectively
- Structured Investigations-Rooted in Accountability
- Real-Time Oversight-Continuous Improvement
Capture Events Early-Respond Effectively
VaultGxP’s Incident Management module provides a centralized system to report, track, and investigate quality or safety incidents across the organization. Whether it’s a laboratory event, equipment malfunction, process deviation, or environmental breach, the platform ensures quick documentation and response. Structured forms, predefined categories, and automated notifications help teams act promptly—minimizing operational disruption and supporting GxP and regulatory compliance from the moment an incident is identified.
Structured Investigations-Rooted in Accountability
Each incident progresses through a guided workflow for triage, root cause analysis, impact assessment, and resolution. Users can assign tasks, collaborate on investigations, and capture supporting evidence—ensuring consistency and transparency. Incidents can be linked to related CAPA, deviation, or audit records for holistic quality oversight. This structured and traceable approach not only supports compliance, but also helps identify patterns and prevent recurrence through targeted actions.
Real-Time Oversight-Continuous Improvement
With secure dashboards, VaultGxP gives QA and leadership teams full visibility into incident trends, response times, and risk areas. The system offers audit trails, electronic approvals, and KPI tracking—making inspection readiness and operational accountability seamless. By digitizing incident reporting and management, VaultGxP reduces manual errors, enhances team collaboration, and supports a culture of continuous quality improvement across all regulated processes.
