Qualio
Electronic quality management system for medical devices, pharmaceuticals, and biotech. Automates gap analysis across FDA, ISO, and EMA standards with cross-mapped evidence reuse.
Qualio is a cloud-based electronic quality management system (eQMS) purpose-built for life science companies. The platform unites quality management, product lifecycle management, and compliance intelligence in a single integrated solution.
Key capabilities
- Document control: Manage SOPs, work instructions, and quality records with version control and electronic signatures
- Training management: Automate training assignments, track completions, and maintain training records
- CAPA management: Track corrective and preventive actions from initiation through closure
- Audit management: Schedule audits, manage findings, and track remediation activities
- Design controls: Support medical device design history files and risk management
- Compliance intelligence: AI-powered gap analysis across 28+ regulatory standards
Industries served
- Medical devices
- Pharmaceuticals
- Biotechnology
- Cannabis
- Software as Medical Device (SaMD)
- Contract Research Organizations (CROs)
Compliance standards
Qualio supports compliance with:
- FDA 21 CFR Part 11
- FDA 21 CFR Part 820 (QSR)
- ISO 13485 (medical devices)
- ISO 9001 (quality management)
- EU MDR (Medical Device Regulation)
- EU IVDR (In Vitro Diagnostic Regulation)
- ICH guidelines
- GAMP 5
Deployment
- Cloud SaaS deployment
- Pre-validated environment (GAMP 5 compliant)
- Typical go-live in 2-4 weeks
- REST API available for integrations
Limitations
- Life sciences vertical focus limits applicability to general manufacturing
- No on-premise deployment option available
- Requires internet connectivity for cloud access
- Limited customization compared to enterprise ERP QMS modules
- Pricing may be prohibitive for very small startups
Qualio and MasterControl compete in the life sciences eQMS market. Both offer FDA-compliant quality management, with MasterControl targeting larger enterprises and Qualio emphasizing rapid deployment for growing companies.
Qualio and Veeva QualityDocs compete in the life sciences quality management space. Veeva is the incumbent with deep CRM integration, while Qualio offers a modern alternative focused on rapid deployment.
Qualio and Sparta Systems TrackWise compete in the life sciences eQMS market. TrackWise is the long-standing incumbent with deep enterprise features, while Qualio offers a modern cloud-native alternative.
Similar to Qualio
