MasterControl

Enterprise FDA/cGMP quality and document control

Visit Website ✓ Verified Jun 9, 2026 Own this product? Claim & verify →
Also works asCompliance & Documentation Software
Deployment
Cloud
Market
Enterprise
Pricing
Custom Quote
Price Range
Contact for Pricing
Founded
1993
HQ
Salt Lake City, Utah, USA
API
Available
FDA CompliantcGMP CompliantEnterprise-Grade

Overview

MasterControl provides FDA and cGMP quality management for enterprise operations handling regulated products. It manages document control, training, and quality processes for life sciences and manufacturing.

Our verdict

Best for regulated life-sciences manufacturers (pharma, medical device, biologics, dietary supplements) that need a validated QMS plus manufacturing execution with deep FDA and ISO compliance support.

Strengths

  • Purpose-built for FDA 21 CFR Part 11 and cGMP-regulated life-sciences quality and document control
  • Public REST and Web Service API toolkit for integrating with ERP, CRM, MES, and PDM systems
  • Holds ISO 27001, ISO 27017, ISO 9001, and ISO 42001 certifications per its official trust page
  • Established vendor since 1993 with strong third-party review scores (4.5 on Capterra and Software Advice)

Watch-outs

  • No public pricing; cost is quote-only and oriented to enterprise budgets
  • Reviewers cite a complex setup and unintuitive interface that require significant training

Assessed by Third Fin Editorial. How we evaluate →

Trust & security

ISO 27001 ✓ Verified source ↗
Other ✓ Verified source ↗
Other ✓ Verified source ↗
cGMP-ready Vendor-stated source ↗
GDPR Vendor-stated source ↗
HIPAA Vendor-stated source ↗

Integrations

Offers an API for custom integrations. Developer docs ↗

Videos

MasterControl Quality Management System (QMS) Whiteboard Overview MasterControl Quality Management System (QMS) Whiteboard Overview MasterControl Quality Management System (QMS) MasterControl Quality Management System (QMS)

Videos are hosted on YouTube and open in a new tab. Third Fin links to, but does not host or endorse, third-party video content.

Reputation & reviews

Capterra 4.5/5 534 reviews as of 2026-06 ↗
Software Advice 4.5/5 534 reviews as of 2026-06 ↗

No reviews for MasterControl yet. Be the first to share your experience.

U.S. Food and Drug Administration (FDA)

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Sources & verification

Last verified Jun 9, 2026 by Third Fin Editorial. See how we evaluate & verify.