Always audit-ready infrastructure: from internal self-inspections to FDA/EMA/TİTCK health authority visits
Comply with ISO 19011 and FDA QMSR: annual audit programs, auditor segregation of duties (SoD), live inspection front room, and FDA 483 commitment tracking.
Audit & Regulatory Inspection Management
Illustrative interface rendering. Real screens and recordings live on the module pages.
Audit & Regulatory Inspection Management
Who it is for: Lead auditors, QA compliance directors, inspection readiness teams, VP of Quality
Smart audit scheduling & SoD enforcement
Annual audit calendars, standard ISO/GMP checklists, and strict rules preventing auditors from auditing their own department.
Authority Inspection Room
Dedicated staging room for FDA/EMA investigators: instant document retrieval, document request logging, and finding management.
Regulatory Commitment Tracker
Day-by-day countdown and escalation tracking for official commitments pledged against FDA 483 or authority observations.
Direct finding-to-CAPA linking
Seamlessly escalates critical, major, and minor audit findings into root-cause analysis and corrective actions.