Qualityze

Claim status: Listed

Services & Capabilities

eQMS Software Comparison

Deployment Model: Cloud (SaaS)
Target Company Size: SME
Modules Included: Document Control, CAPA, Change Control, Training Management, Complaint Handling, Supplier Management, Risk Management, Audit Management, Design Control
Compliance Standards: ISO 13485:2016, FDA QMSR (21 CFR Part 820), EU MDR/IVDR, MDSAP, 21 CFR Part 11, ISO 14971
Validation Pack Available: Yes
Part11 Support: Yes
Implementation Timeline: Custom
Integration Options: ERP, MES, PLM, CRM, Other
Data Migration Support: Yes
Training Support: Yes
API Access: Yes
Regions Served: Global
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Cruxi - Regulatory Compliance Services