Deployment Model:
Cloud (SaaS)
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, 21 CFR Part 11, Other
Validation Pack Available:
Yes
Part11 Support:
Yes
Implementation Timeline:
3-6 months
Integration Options:
Microsoft Office 365
Data Migration Support:
Yes
Training Support:
Yes