GxP service providers need to meet compliance requirements across the life sciences value chain. Each new standard requires re-building processes. Qualio helps you adopt new standards 3x faster.
Quality & Compliance for CROs and CDMOs
Win more clients. Keep them longer.
Compliance is your competitive edge. Build in clause-level GxP compliance from the start.
Trusted by leading service providers to life sciences
The Solution
50+ sponsor audits? No problem
Audit-readiness on autopilot
Build in clause-level compliance with FDA, ISO, and GxP standards, monitor for regulatory updates and risks, and catch issues before they become findings.
Standardize on one system
Unify documents, training, events, and third-party management across every client and site in one place, with complete visibility into your processes in real time.
Eliminate compliance admin
Pre-built templates, automated workflows, and simple onboarding mean your team spends less time managing the QMS and more time delivering for clients.
Results service providers are achieving:
- 3x more frameworks pursued in parallel, Cogstate
- Reactive compliance to continuous monitoring, AGADA
- 50% reduction NCRs/serious deviations, Wellcome-HRB Clinical Research Facility
Multi-Client Quality Management
- Manage quality processes across multiple clients and programs in one system with full separation and traceability
- Scale to new clients and therapeutic areas without rebuilding your QMS
- Give sponsors controlled visibility into your quality system to demonstrate operational integrity
Continuous Audit Readiness
- Out-of-the-box frameworks for FDA, ISO, ICH, and GxP requirements
- Clause-level evidence mapping so gaps are visible in real time, not discovered at audit
- Custom framework support for sponsors with specific quality requirements
- Exec dashboards to monitor site-level compliance
Automated Quality Workflows
- Document control, change control, training, CAPA, and event management with automated routing, reminders, and audit trails
- End-to-end traceability from quality event to root cause across every client project
- 21 CFR Part 11 e-records and e-signature compliance out of the box
Don't just take our word for it!
Hear from our innovative customers
Related resources
Resources for contract research and manufacturing professionals
See Qualio in Action
The quality system your sponsors expect. The simplicity your team needs.
See how CROs and CDMOs use Qualio to win sponsor confidence and scale without compliance overhead.