MasterControl
MasterControl Solutions, Inc
★★★★★
4.5
/ 5
•
47 reviews
MasterControl offers a connected QMS and AI platform for life sciences manufacturers, accelerating quality processes, ensuring compliance, and automating document control for improved audit readiness.
MasterControl provides an innovative, compliant architecture designed to connect quality, manufacturing, and asset management for life sciences organizations. Their secure, specialized AI platform helps manufacturers accelerate quality processes, ensure compliance, and eliminate manual errors. Key benefits include reducing validation time from weeks to minutes with patented tools, uncovering trends for faster decision-making with MasterControl Insights, and automating document control for enhanced accuracy, visibility, and audit readiness. They also facilitate efficient change management with full traceability and cross-team collaboration, making them a comprehensive solution for QMS needs. With a focus on industries like life sciences, MasterControl's solutions are purpose-built to address specific regulatory requirements and operational challenges. Their platform supports critical functions such as CAPA management, document control, and training management, all within a unified system. This integrated approach aims to streamline operations, reduce risk, and improve overall product quality and market speed. The company emphasizes flexibility in pricing to meet diverse business needs and offers resources such as webinars, blogs, and a resource center to support their clients. MasterControl's commitment extends to providing robust solutions for FDA-regulated environments, as evidenced by their focus on QMS for the FDA and their expertise in areas like Corrective Action (CAPA) software. They aim to empower organizations to achieve operational excellence and maintain a strong compliance posture through advanced technology and dedicated support.
About
**Who they are**
MasterControl is a provider of a connected Quality Management System (QMS) and AI platform specifically designed for life sciences manufacturers. They focus on accelerating quality processes and ensuring compliance.
**Expertise & scope**
* Offers a secure, specialized AI platform for life sciences manufacturers.
* Provides tools to reduce validation time from weeks to minutes.
* Delivers capabilities for uncovering trends and making faster decisions through MasterControl Insights.
* Specializes in CAPA (Corrective Action and Preventive Action) management software, described as the engine that drives quality.
* Focuses on connecting quality, manufacturing, and asset management with an innovative, compliant architecture.
**Reputation / proof points**
* The QMS Provider for the FDA.
MasterControl is a provider of a connected Quality Management System (QMS) and AI platform specifically designed for life sciences manufacturers. They focus on accelerating quality processes and ensuring compliance.
**Expertise & scope**
* Offers a secure, specialized AI platform for life sciences manufacturers.
* Provides tools to reduce validation time from weeks to minutes.
* Delivers capabilities for uncovering trends and making faster decisions through MasterControl Insights.
* Specializes in CAPA (Corrective Action and Preventive Action) management software, described as the engine that drives quality.
* Focuses on connecting quality, manufacturing, and asset management with an innovative, compliant architecture.
**Reputation / proof points**
* The QMS Provider for the FDA.
Additional information
MasterControl's CAPA management software is positioned as a core component for driving quality within life sciences organizations. Their platform aims to streamline processes by connecting quality, manufacturing, and asset management. For buyers looking to improve audit readiness and automate document control, MasterControl highlights its AI capabilities and patented validation tools designed to significantly reduce project timelines. They also offer flexible pricing plans to accommodate various business needs.
Key Highlights
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Offers a connected QMS and AI platform for life sciences manufacturers.
Source
“Discover MasterControl’s secure, specialized AI platform for life sciences manufacturers.”
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Provides patented tools to reduce validation time from weeks to minutes.
Source
“Reduce validation from weeks to minutes with MasterControl’s patented validation tools.”
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Enables trend analysis and faster decision-making with MasterControl Insights.
Source
“Uncover trends and make better decisions faster with MasterControl Insights.”
Certifications & Trust Signals
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Identified as 'The QMS Provider for the FDA'.
Source
“The QMS Provider for the FDA”
Buyer Snapshot
Best for
- Life sciences manufacturers seeking integrated QMS and AI solutions
- Companies needing to accelerate quality processes and improve audit readiness
- Organizations focused on automating document control and CAPA management
How engagement typically works
- Platform-based solutions
- Focus on automation and efficiency gains
Typical deliverables
- Connected QMS and AI platform
- CAPA management software
- Document control automation
- Validation tools
- Data analytics for decision making
Good to know
- Best when seeking a comprehensive QMS solution for regulated industries.
Pricing
Model:
Custom pricing
HQ:
Salt Lake City, US
Languages:
English
Timezones:
MST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US, EU
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
14–30 days
Pricing model:
Custom pricing
Service Types:
CAPA & Nonconformance Remediation, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start:
flexible
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
CAPA & Nonconformance Remediation, Training & Competency Programs
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
