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