Complere eQMS

An electronic quality management system (eQMS) that connects quality records, actions, people, and evidence into one operating system for regulated teams. It solves the problem of managing compliance across document control, CAPA, audits, training, change, and risk in a single, validated platform. The product sells to quality, operations, IT, and executive roles in pharmaceutical, biotech, medical device, and other regulated industries, including mid-market and enterprise companies. It is positioned as a validation-ready foundation with Part 11–friendly controls, connected traceability, and inspection-ready workflows, delivered as a SaaS platform with a pilot approach for phased rollout.

Key features

• Document control lifecycle management
• CAPA and deviation management
• Audit management for internal and supplier audits
• Training and competency tracking
• Change control with impact assessment
• Risk assessment with scoring
• Compliance intelligence with regulatory context
• Dashboards and KPIs for executive visibility
• Management review with controlled minutes
• Integrations with identity, engineering, lab, MES, ERP, HR systems
• Validation approach with IQ/OQ/PQ alignment
• Part 11-aligned electronic signatures and audit trails
• RBAC, 2FA, SSO, tenant isolation, GDPR controls