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MasterControl Quality Management System
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What MasterControl Quality Management System is
MasterControl Quality Management System, presented as Quality Excellence, is a cloud-based QMS for life sciences and other regulated industries. It manages quality activities across the product life cycle, including document control, audits, corrective actions, nonconformance tracking, compliance records, and approval workflows. A no-code designer lets teams create and modify quality-event forms and workflows, with rules-based routing, AI-generated event summaries, and deviation trend identification. Document management includes version control, electronic signatures, archiving, collaboration, searchable records, and 21 CFR Part 11 compliance. Training tools schedule, route, track, and follow up on assignments, while supporting role-based exams and competency records. Additional processes cover CAPA, change control, customer complaints, deviations, and nonconformance management. Integrations connect with ERP, MES, LIMS, CRM, and other enterprise systems through PaaS and REST API tools; API access requires an API license. Mobile access covers documents, tasks, and processes. Pricing is available on request, with named-user licensing and cloud deployment.
Who it suits
This QMS is intended for pharmaceutical, medical-device, biotech, and other regulated organizations managing quality and compliance processes. It suits teams needing document, training, audit, and corrective-action workflows in one cloud system.
What it does well
- No-code quality workflow designer
- Document version control and eSignatures
- Covers CAPA, audits, and nonconformance
- Mobile access to tasks and documents
- Integrates with enterprise systems
What to know first
- Pricing available only on request
- API access requires a separate license
- Cloud deployment only
Limits
Pricing is tailored to the organization and packages range from basic document management to a complete digital QMS. API access requires an API license.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| MasterControl Quality Excellence | Pricing tailored to organization; named-user licensing; packages range from basic document management to a complete digital QMS | On request |
As mastercontrol.com lists them, read 9 Oct 2026. The maker's own page has the final word.
Getting started
- Open the MasterControl Quality Management System website.
- Request pricing tailored to your organization.
- Choose a package from document management to a complete digital QMS.
- Deploy Quality Excellence as a cloud QMS.
- Access documents, tasks, and processes through the web or mobile app.
- Obtain an API license if REST API access is required.
Verdict
MasterControl combines regulated-quality processes, document controls, training, and integrations in a cloud QMS. Organizations should confirm package scope, named-user licensing, and API licensing before choosing it.
Questions
What does MasterControl Quality Management System cost?
Pricing is available on request and tailored to the organization.
Is there a free plan?
No. The product uses a paid pricing model.
Which platforms can access the QMS?
It supports Android, iOS, web access, and API connectivity; mobile access works on smartphones and tablets.
What industries is it intended for?
MasterControl presents it for life sciences and other regulated industries, including pharmaceutical, medical device, and biotech organizations.
What integrations are supported?
MasterControl describes integrations with ERP, MES, LIMS, CRM, and other enterprise systems through PaaS and REST API tools.
Does API access require anything extra?
Yes. MasterControl API access requires an API license.
Facts from MasterControl Quality Management System's own pages
- API
- MasterControl API access requires an API license. · currentcloud.onlinehelp.mastercontrol.com, 9 Oct 2026
- Cloud
- MasterControl describes Quality Excellence as a cloud-based QMS and says its SaaS offerings are available to regulated customers. · mastercontrol.com, 9 Oct 2026
- Documents
- Document management supports version control, eSignatures, archiving, collaboration, searchable records, and 21 CFR Part 11 compliance. · mastercontrol.com, 9 Oct 2026
- Headquarters
- Salt Lake City, Utah, United States · mastercontrol.com, 28 Sept 2026
- Integrations
- MasterControl describes connecting the QMS with ERP, MES, LIMS, CRM, and other enterprise systems through PaaS and REST API integration tools. · mastercontrol.com, 9 Oct 2026
- Intended users
- The product is presented for life sciences and other regulated industries, including pharmaceutical, medical device, and biotech organizations. · mastercontrol.com, 9 Oct 2026
- Mobile access
- MasterControl Mobile lets users access documents, tasks, and processes on a tablet or smartphone. · mastercontrol.com, 9 Oct 2026
- Other quality processes
- The QMS includes capabilities for CAPA, change control, audits, customer complaints, deviations, and nonconformance management. · mastercontrol.com, 9 Oct 2026
- Purpose
- Quality Excellence automates quality across the product life cycle to help regulated companies manage compliance, streamline processes, and support growth. · mastercontrol.com, 9 Oct 2026
- Quality events
- Quality event forms and workflows can be built and modified with a no-code designer, with rules-based routing and AI-generated event summaries and deviation trend identification. · mastercontrol.com, 9 Oct 2026
- Security and standards
- MasterControl's AI Trust Center lists ISO 27001 information security, ISO 27017 cloud security, ISO 27701 privacy information management, and ISO 42001 AI management among its standards. · mastercontrol.com, 9 Oct 2026
- Support
- MasterControl says its technical support program includes automatic software upgrades and unlimited technical assistance by email or telephone from 6 a.m. to 6 p.m. · mastercontrol.com, 9 Oct 2026
- Training
- Training management schedules, routes, tracks, and follows up on training tasks and supports role-based exams and competency records. · mastercontrol.com, 9 Oct 2026
Where MasterControl Quality Management System stands on Freedom251
- Quality Management Software#17 of 37