Description
Key Features and Benefits
- Document & Records Management – Automates ISO-compliant document control with version tracking, audit trails, and electronic signatures for regulatory compliance.
- Audit Management – Centralized repository for audits with automated scheduling, CAPA triggers, escalation workflows, and customizable reports.
- Corrective and Preventive Actions (CAPA) – Tracks root causes, automates corrective action planning, and ensures issue resolution through AI-driven risk mitigation.
- Risk Management & Compliance – Proactive risk assessment tools aligned with ISO, FDA, HIPAA, and SOX standards to prevent non-compliance issues.
- Supplier & Product Management (SCAR) – Monitors supplier performance, automates corrective action requests, and integrates with ERP for procurement quality control.
- Training & Compliance Management – Automates employee training, tracks compliance certifications, and ensures audit readiness with complete documentation.
- Non-Conformance & Complaint Handling – Captures and categorizes non-conformance events, links them to audits and CAPA, and prevents recurrence with corrective actions.
Key Differentiators
- AI-Powered Insights & Analytics – Uses machine learning and predictive analytics for quality improvements.
- Low-Code Digital Business Platform – Customizable without heavy IT involvement.
- Enterprise Process Center® (EPC) Integration – A comprehensive BPM suite for governance, risk, and compliance (GRC).
- Multi-Industry Support – Ideal for pharmaceuticals, healthcare, manufacturing, food & beverage, and regulated industries.
