Compliance & Validation — Documented
ISO 27001
Qualio
Cloud eQMS for life sciences with AI-assisted document, training, and compliance-gap workflows aimed at scaling companies.
Qualio, founded in 2012 in Dublin and now headquartered in San Francisco, California, provides a cloud electronic quality management system for life sciences companies — document control, training, CAPA, design controls, and supplier management — with AI-assisted compliance-gap analysis and regulatory monitoring features. The company has raised approximately $63.9 million through a Series B led by Tiger Global and reports over 650 customers, primarily startups and scaling companies. It documents ISO 27001, ISO 27701, and ISO 9001 certifications; no SOC 2 attestation was surfaced on public pages at profiling time.
- Headquarters
- San Francisco, United States
- Founded
- 2012
- Compliance
- ISO 27001
- Deployment options
- cloud
- Website
- https://qualio.com
- https://www.linkedin.com/company/qualio
Categories
AI Use Cases
- Manufacturing Quality Control
Vendor Scorecard
71% — Complete coverage. Coverage score — how completely Atlas documents Qualio across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Biotech Startup, Mid-Size Biotech, IT / Digital, Data Management
Solution Scope — Documented
Manufacturing Quality Control
Company Viability — Documented
Series B, $63.9M raised, Founded 2012
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Questions to Ask This Vendor
- Which AI quality features are in production, and how are outputs validated?
- How does the platform scale if we grow past the mid-size segment?
- Is a SOC 2 report available in addition to ISO certifications?
- What does validation documentation for regulated use look like?