Startups > MasterControl

MasterControl

MasterControl helps life sciences manufacturers automate quality and regulatory compliance workflows.

Series A $150M total Founded 1993 Salt Lake City, Utah 774 employees

MasterControl provides quality management and manufacturing execution software for life sciences companies navigating regulated product development and commercialization. The platform automates GxP (Good Practice) workflows across quality, compliance, supply chain, clinical trials, and product development. Built specifically for FDA-regulated industries, MasterControl has evolved from document management to a comprehensive quality operations platform trusted by 1,250+ companies and nearly 1 million users globally.

Problem solved

Life sciences manufacturers spend excessive time on manual quality documentation, regulatory compliance, and manufacturing execution processes instead of accelerating product development and commercialization.

Target customer

Life sciences companies (biotech, pharma, medical devices, contract manufacturers) ranging from early-stage startups to global enterprises requiring FDA compliance and quality management systems.

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Founders

Jon Beckstrand

CEO

Former Manager at KPMG Peat Marwick, attended BYU Law School, became Chairman in 2002 and led company transformation from document control to quality management platform.

Mark Tanner

Co-founder

Co-founder who identified the need for better quality solutions in regulated industries.

Funding history

Series A $150M December 15, 2022 Led by Sixth Street Growth · PPP

Total raised: $150M

Industries

Product Management Life Science Quality Assurance Productivity Tools Software

Pricing

Named-user license model starting at $1,000/month ($25k-$100k annually). Per-user licensing costs approximately $1,700. Multi-tiered packages available: pre-configured solutions for emerging companies to flexible enterprise packages. Customers select modules and scale over time. Validation Excellence Tool (VxT) and Validation on Demand (VoD) included.

Notable customers

1,100+ customers including Almac Sciences, Northeast Scientific, and 1,250+ companies worldwide; nearly 1 million users globally

Integrations

Not explicitly detailed in research; platform supports connected applications for automation and integration across product development processes

Tech stack

Lodash (JavaScript libraries) jQuery (JavaScript libraries) core-js (JavaScript libraries) Microsoft ASP.NET (Web frameworks) Bootstrap (UI frameworks) YouTube (Video players) Open Graph Zendesk (Documentation) Sitefinity (CMS) Linkedin Insight Tag (Analytics) Google Analytics (Analytics) Facebook Pixel (Analytics) Demandbase (Analytics) Adobe Analytics (Analytics) reCAPTCHA (Security) Imperva (Security) HSTS (Security) IIS (Web servers) Windows Server (Operating systems) Salesloft (Marketing automation) Marketo (Marketing automation) Twitter Ads (Advertising) Microsoft Advertising (Advertising) Adobe Experience Platform Launch (Tag managers) Amazon Web Services (PaaS) OneTrust (Cookie compliance) DigiCert (SSL/TLS certificate authorities) Google Optimize (A/B Testing) Sendgrid (Email) Amazon SES (Email) Adobe Experience Platform Identity Service (Customer data platform)

Website

mastercontrol.com/

Competitors

Propel Software

General quality management competitor with less life sciences specialization.

AssurX

Broader compliance platform; MasterControl focuses more deeply on manufacturing execution and quality workflows.

ETQ

Enterprise quality management platform serving multiple industries; MasterControl is life-sciences-specific.

Honeywell Life Sciences

Larger conglomerate offering; MasterControl purpose-built for regulated life sciences workflows.

ValGenesis

Specialized in validation tools; MasterControl offers broader quality and manufacturing execution suite.

Why this matters: MasterControl is a rare example of a 30-year-old company achieving unicorn status ($1.3B valuation) with its first outside funding ($150M Series A in 2022), indicating sustained product-market fit in the highly regulated life sciences space. The company's evolution from document management to specialized quality operations platform, combined with its acquisition strategy and market leadership position, demonstrates strong moat-building in regulated industries where switching costs are high.

Best for: Life sciences manufacturers and contract manufacturers who need to accelerate product development while maintaining FDA compliance and quality standards across manufacturing and supply chain operations.

Use cases

Accelerating Manufacturing Cycles

Almac Sciences implemented MasterControl Manufacturing Excellence and reduced production cycles from months to days for complex peptide manufacturing. The platform automated quality workflows and documentation, allowing faster manufacturing execution without sacrificing regulatory compliance.

Eliminating Paper-Based Processes

Northeast Scientific eliminated paper documentation and reduced time-to-market by digitizing all quality documentation. The platform prevents lost or damaged documents and accelerates completion of critical compliance documentation.

Regulatory Compliance at Scale

Life sciences companies use MasterControl to manage FDA-required GxP workflows across development, manufacturing, supply chain, and clinical trials. The platform automates compliance documentation and maintains audit trails required for regulatory submissions.

Alternatives

Haast Smaller, more agile competitor; MasterControl offers more enterprise-grade features and broader feature set.

Tulip Interfaces Manufacturing operations focus with lower FDA compliance depth; better for general manufacturing than regulated life sciences.

Oracle QMS Large enterprise platform serving multiple industries; MasterControl provides more specialized life sciences workflows and easier implementation for mid-market companies.

FAQ

What does MasterControl do? +

MasterControl provides quality management and manufacturing execution software for life sciences companies. It automates GxP (Good Practice) workflows for quality, compliance, supply chain, clinical trials, and product development. The platform helps regulated manufacturers accelerate product development while maintaining FDA compliance and quality standards.

How much does MasterControl cost? +

MasterControl uses a named-user license model starting at $1,000/month ($25k-$100k annually, roughly $2k-$8k/month). Per-user licensing costs approximately $1,700. Multi-tiered packages are available from pre-configured solutions for startups to flexible enterprise packages, with customers able to select and scale modules over time.

What are alternatives to MasterControl? +

Key alternatives include AssurX (broader compliance platform), ETQ (enterprise quality platform), Honeywell Life Sciences (larger conglomerate offering), ValGenesis (validation-focused), and Tulip Interfaces (manufacturing operations). Oracle also offers QMS solutions as an enterprise option.

Who uses MasterControl? +

MasterControl serves 1,250+ life sciences companies globally, including pharmaceutical, biotech, medical device, and contract manufacturing organizations ranging from early-stage startups to global enterprises. Notable customers include Almac Sciences and Northeast Scientific. Nearly 1 million users rely on the platform worldwide.

How does MasterControl compare to AssurX? +

Both are quality management platforms, but MasterControl is specifically optimized for life sciences manufacturing and regulatory workflows, while AssurX is a broader compliance platform serving multiple industries. MasterControl has deeper manufacturing execution capabilities and faster implementation for mid-market life sciences companies. MasterControl was named the #1 QMS in life sciences.