Frequently asked questions

The system captures quality incidents, safety events, contamination events, near misses, system failures, and operational disruptions. During impact assessment, incidents affecting product quality (SISPQ) are classified as deviations and routed to the Deviation module, while non-quality-impact incidents continue within the Incident module.

Yes. Incidents can be seamlessly linked to the CAPA module, enabling initiation and tracking of corrective and preventive actions with full traceability from identification through effectiveness verification.

Configurable SLA timelines, automated reminders, and escalation alerts ensure incidents are investigated and closed within defined timeframes.

Every action, comment, approval, and status change is timestamped and attributed to the user, creating a secure, immutable, and inspection-ready audit trail.

Yes. The module generates structured reports including incident details, impact assessment, investigation findings, and actions taken  suitable for both regulatory and internal reviews.

Yes. Trend dashboards enable analysis by incident type, department, product, or time period, helping identify recurring issues and systemic risks.

Yes. The system is accessible on network connected devices, allowing real-time incident reporting at the point of occurrence by production and QA teams.

Yes. The system supports cross functional collaboration with role-based task assignments, enabling multiple departments to participate in investigation, review, and closure.

Yes. The module complies with 21 CFR Part 11 and EU Annex 11, supporting electronic signatures, audit trails, secure user access, and data integrity controls to ensure all records are secure and audit-ready.