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Document Control
Document control with SOPs and version tracking
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Capacidades
Todo lo que necesita en un solo módulo
Control Plans
Define quality control plans at product and operation level with inspection frequency, methods, and acceptance criteria.
SPC & Statistical Analysis
Built-in Statistical Process Control with X̄-R charts, capability indices (Cp, Cpk), and out-of-control alerts.
Sampling Plans
AQL-based sampling plans (ANSI/ASQ Z1.4 & Z1.9) with automatic lot accept/reject decisions.
Non-Conformance Management
NCR workflow from detection through disposition with 8D CAPA, root cause analysis, and effectiveness verification.
Audit Trail & 21 CFR Part 11
Tamper-evident audit trail with electronic signatures meeting 21 CFR Part 11 and ISO 13485 requirements.
Certificate of Analysis
Auto-generate CoA documents from inspection results with digital signature and customer-specific templates.
Detalles técnicos
Especificaciones y requisitos
¿Necesita una cotización a medida?
Descuentos por volumen para despliegues en varias plantas. Nuestro equipo dimensiona el paquete adecuado para su planta.
Prueba de concepto gratuita para proyectos calificados
Pago flexible: perpetuo o SaaS
Soporte de implementación dedicado
