Compliance & Validation — Documented
GxP validated, ISO 27001, 21 CFR Part 11
MasterControl
Quality and manufacturing management platform (eQMS/MES) with AI features for regulated production and quality workflows.
MasterControl, founded in 1993 and headquartered in Salt Lake City, Utah, provides quality management and manufacturing execution software used across regulated industries, with AI capabilities in document processing, production records, and quality event management. The company reported passing $200 million in annual recurring revenue in 2025 and holds ISO 27001, 27017, 27018, and 9001 certifications; it documents how the platform supports FDA 21 CFR Part 11 and Annex 11 compliance. SOC reports referenced on its trust page belong to its AWS hosting provider — Atlas does not treat inherited infrastructure certifications as vendor-held.
- Headquarters
- Salt Lake City, United States
- Founded
- 1993
- Compliance
- ISO 27001, 21 CFR Part 11
- Deployment options
- cloud
- Website
- https://www.mastercontrol.com
- https://www.linkedin.com/company/mastercontrol
Categories
AI Use Cases
- Manufacturing Quality Control
Vendor Scorecard
64% — Partial coverage. Coverage score — how completely Atlas documents MasterControl across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Mid-Size Biotech, Large Pharma, Top 20 Pharma, IT / Digital, Data Management
Solution Scope — Documented
Manufacturing Quality Control
Company Viability — Partially documented
Private, Founded 1993
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Questions to Ask This Vendor
- Which AI features are in production at pharma customers, and what accuracy evidence exists?
- How is Part 11 compliance documentation delivered for our validation package?
- What does integration with our existing ERP and LIMS landscape look like?
- How are quality and manufacturing modules licensed — together or separately?