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Quality and manufacturing software for life sciences
MasterControl is a quality management platform offering a validated QMS and manufacturing execution suite built for FDA-regulated life sciences. Founded in 1993 and based in Salt Lake City, Utah, USA, MasterControl helps pharma, biotech and medical device quality teams manage compliance, reduce risk and stay audit-ready across sites.
MasterControl is built for pharma, biotech and medical device quality teams. It suits organizations that need document control and training management and want quality and safety processes standardized rather than run on spreadsheets.
Compared with alternatives like Qualio, MasterControl differentiates on document control and training management. Pricing is quote-based and scoped to your modules, users and sites, so it fits established quality management programs.
Pricing Model
Quote-based
Starting Price
Contact vendor
Free Options
Free trial
Core MasterControl for a single site or team. Contact for a quote.
Advanced MasterControl for multi-site, regulated programs. Contact for a quote.
| Feature | Professional Popular | Enterprise |
|---|---|---|
| document control and training management | , | |
| CAPA and change control | , | |
| validated for FDA and GxP | , | |
| Audit trails and reporting | , | |
| Standard integrations | , | |
| Everything in Professional | , | |
| manufacturing and quality execution | , | |
| Validation support and e-signatures | , | |
| SSO and enterprise security | , | |
| Dedicated support and onboarding | , |
Other
CRM
HR & People
Authentication
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API Types
SDK Availability
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Developer Features
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Compliance Standards
SOC 2 Type II
EnterpriseISO 27001
EnterpriseGDPR Compliant
GlobalHIPAA
HealthcarePCI DSS
FinanceCCPA
PrivacyFedRAMP
GovernmentCSA STAR
CloudDeployment & Data
Data Residency Options
Verify with vendor for your specific region requirements.
Inspection, checklist, and operations platform for frontline teams
Cloud quality management system for growing life-sciences teams
Quality management and regulatory compliance platform
Quick comparisons
