MasterControl
Cloud quality management and document control system for regulated life sciences manufacturing.
MasterControl is a quality management and document control system for regulated industries, above all pharmaceuticals, biotechnology, and medical devices. It manages controlled documents and revisions, change control, CAPA, deviations and nonconformances, audits, supplier quality, complaints, and training records, with electronic signatures and audit trails that support FDA 21 CFR Part 11, ISO 13485, and GxP requirements. MasterControl Manufacturing Excellence extends the same platform to electronic batch records and production execution on the shop floor.
Key capabilities
- —Controlled document management with revision and audit history
- —Change control, CAPA, deviations, and nonconformance handling
- —Audit, supplier quality, and complaint management
- —Training records and electronic signatures (21 CFR Part 11)
- —Electronic batch records and production execution
- Type
- QMS System
- Vendor
- MasterControl
- Deployment
- Cloud, On-premise
- Category
- QMS
- Typical company size
- Mid-market to large enterprise
- Installed seats / users
- Not publicly disclosed by the vendor
- Implementation effort
- Medium
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