MasterControl

MasterControl Solutions, Inc
★★★★★ 4.5 / 5
• 48 reviews

Quality management system for life sciences and regulated manufacturing.

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 quality management system (QMS) software, specifically designed for life sciences and regulated manufacturing industries. They focus on delivering a compliant and innovative architecture that connects quality, manufacturing, and asset management processes.

**Expertise & scope**
* Specialized AI platform for life sciences manufacturers.
* Tools to reduce validation time from weeks to minutes.
* Solutions for uncovering trends and improving decision-making.
* Offers flexible pricing plans tailored to business needs.
* Expertise in Quality Management Software (QMS), Corrective Action (CAPA) software, Document Control software, and Change Control software.

**Reputation / proof points**
* Meets FDA and ISO 9001:2015 requirements.
* Recognized as a leading QMS provider for life sciences.

Additional information

MasterControl's platform is built to streamline quality processes, particularly for organizations in regulated sectors. Their solutions aim to enhance efficiency in areas like document control, CAPA management, and change control. The software is designed to integrate quality, manufacturing, and asset management, providing a connected ecosystem. Buyers can expect features that facilitate compliance with standards such as FDA regulations and ISO requirements. The platform's AI capabilities are geared towards improving operational insights and reducing validation efforts, making it a strategic tool for life science and manufacturing companies seeking to optimize their quality systems.

Key Highlights

  • Offers a specialized AI platform for life sciences manufacturers. Source
    “Discover MasterControl’s secure, specialized AI platform for life sciences manufacturers.”
  • Reduces validation time from weeks to minutes with patented tools. Source
    “Reduce validation from weeks to minutes with MasterControl’s patented validation tools.”
  • Provides tools for uncovering trends and making faster decisions. Source
    “Uncover trends and make better decisions faster with MasterControl Insights.”
  • Meets FDA and ISO 9001:2015 requirements. Source
    “MasterControl Meets FDA and ISO 9001:2015 Requirements”

Certifications & Trust Signals

  • MasterControl is a leading QMS provider for the FDA. Source
    “The QMS Provider for the FDA”

Buyer Snapshot

Best for
  • Life sciences manufacturers
  • Regulated manufacturing organizations
  • Companies seeking to streamline quality processes
How engagement typically works
  • Software-as-a-Service (SaaS) platform
  • Focus on AI-driven insights
  • Emphasis on reducing validation time
Typical deliverables
  • Quality Management System (QMS) software
  • Corrective Action (CAPA) software
  • Document Control software
  • Change Control software
  • AI-powered analytics and reporting
Good to know
  • Best when organizations require a robust, compliant QMS for regulated industries.

Pricing

Model: Custom pricing
HQ: Salt Lake City, US
Languages: English
Timezones: MST
Claim 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

eqms_software_comparison

Pricing model: Custom pricing
Deployment Model: Cloud (SaaS)
Modules Included: Document Control, CAPA, Change Control
Compliance Standards: FDA QMSR (21 CFR Part 820), 21 CFR Part 11, ISO 13485:2016
Part11 Support: Yes
Validation Pack Available: Yes
Integration Options: ERP, MRP, Production Operations Management, LIMS
Demo Url: https://www.mastercontrol.com/quality/qms/
Pricing Page Url: https://www.mastercontrol.com/quality/qms/
Validation Docs Url: https://www.mastercontrol.com/quality/qms/
Part11 Docs Url: https://www.mastercontrol.com/quality/qms/
Training Support: Yes
Implementation Timeline: Custom
API Access: Yes

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, CAPA & Nonconformance Remediation, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
Request quotes
Cruxi - Regulatory Compliance Services