Quality

Quality Control

Comprehensive quality management for manufacturing — define control plans, execute inspections, apply statistical sampling plans, and maintain full audit trails for ISO and FDA compliance.

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Funktionen

Alles, was Sie brauchen, in einem Modul

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.

Technische Details

Spezifikationen & Anforderungen

Min. atvise® version	3.8.0
Standards compliance	ISO 9001, ISO 13485, IATF 16949
Regulatory	21 CFR Part 11, EU MDR ready
Database	PostgreSQL 14+
SPC chart types	X̄-R, X̄-S, I-MR, p, np, c, u
LIMS integration	REST API connector
License model	Per plant site
Support tier	Standard + Premium available

€2.150einmalig

Unbefristete Lizenz · Jährliche Wartung optional · Inklusive Updates im ersten Jahr

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Mengenrabatte für Installationen an mehreren Standorten. Unser Team stellt das passende Paket für Ihre Anlage zusammen.

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