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Annual audit planner with risk-based frequency assignments and annual audit calendar per department, process, and site

Automated audit planning and scheduling with intelligent resource allocation and scope definition across all audit types

Internal and external audit management with configurable checklists aligned to FDA, EU GMP, ISO 9001, ISO 13485, and ICH Q10

Real-time audit execution with on-the-spot observation recording, evidence attachment, and photo capture

Audit findings and CAPA integration — classify findings (Critical, Major, Minor, Observation) with automated CAPA generation for critical/major findings

Supplier and vendor audit management with qualification scoring, vendor audit tracking, and re-qualification scheduling

Third party audit management for contract auditors and external audit firms with document sharing and virtual observation

Regulatory inspection readiness dashboard — pharmaceutical inspection readiness software showing open findings, overdue CAPAs, and compliance KPIs per site

Supplier quality audits with risk-based supplier segmentation and audit frequency determination

Audit analytics and reporting with trend analysis, closure rates, and regulatory audit management software dashboards