CloudPer User/Month
Qualio
Cloud QMS built for startup and scale-up life sciences companies with simplified compliance workflows.
Medical DevicePharmaceuticals & BiotechnologyBiotechnology
Early-stage life sciences companies needing rapid ISO 13485/FDA readiness
Starting: $500/month (up to 10 users) · Implementation: Included in subscription · Contract: Annual (monthly available at premium)
Visit Qualio
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Visit Website →Feature Overview
Key capabilities of Qualio.
Mobile inspections
Offline mode
Real-time SPC
Supplier portal
Training management
Audit management
API access
21 CFR Part 11
AI-powered insights
Platform customizability
Compliance Certifications
Free trial
NC & CAPA Workflows
Tool Calibration & Metrology
Document Control Sign-offs
Shop Floor Integration
Detailed Specifications
Company Profile
- Founded
- 2012
- Employees
- 150+
- Headquarters
- San Francisco, CA, USA
- Target Size
- Mid-market
Compliance & Validation
- Validation Status
- Validation Ready
- Implementation Speed
- Fast (4–12 weeks)
- Implementation Time
- 6 weeks
- Trial Available
- Sandbox/POC (14 days)
Pricing Details
- Model
- Per User/Month
- Starting Price
- $500/month (up to 10 users)
- Implementation Fee
- Included in subscription
- Training Included
- Yes
- Contract Term
- Annual (monthly available at premium)
Notable Customers
- Cerus
- Endotronix
- Neurocrine
- Spark Therapeutics
- Verily
Integrations
JiraAsanaSlackMicrosoft TeamsBoxGoogle DriveDocuSign
Support & SLA
- SLA
- Same-day response during business hours
EmailChatKnowledge Base
Technical Details
- Mobile App
- No
- Offline Capability
- No
- Languages
- English
- Data Residency
- US, EU
- Security Certs
- SOC 2 Type II, ISO 27001
- API Docs
- View Documentation
Compliance Matrix
Qualio alignment with key regulatory standards.
| Standard / Regulation | Supported |
|---|---|
| ISO9001 | |
| ISO13485 | |
| ISO14971 | |
| FDA21CFR820 | |
| FDA21CFR11 | |
| MDSAP | |
| EUMDR | |
| IATF16949 | |
| AS9100 |
Certifications
ISO 13485FDA 21 CFR 820FDA 21 CFR Part 11
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