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Platform & AI

Platform & AI

Platform

Innovative, compliant architecture connecting your quality, manufacturing, and asset management.

AI

Discover MasterControl’s secure, specialized AI platform for life sciences manufacturers.

Validation

Reduce validation from weeks to minutes with MasterControl’s patented validation tools.

Data & Analytics

Uncover trends and make better decisions faster with MasterControl Insights.

Integrations

ERP Software System
MRP Software System
Manufacturing Resource Planning
Production Operations Management
LIMS System
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Pricing

Learn more about flexible pricing plans to meet your business needs.

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Quality

Quality Excellence Suite

QMS Overview

Accelerate quality processes, ensure compliance, and eliminate manual errors with a connected QMS.

Document Control

Automate document control to improve accuracy, visibility, and audit readiness.

Change Control

Manage changes efficiently with full traceability and collaboration across teams.

Training Management

Keep your workforce trained, qualified, and audit-ready with integrated training management.

Audit Management

Take the stress out of audits with automated prep, execution, and follow-up.

Risk Management

Proactively identify and mitigate risk across your product lifecycle and quality processes.

Quality Event Management

Capture, track, and resolve quality events with a flexible, connected system.

Quality Management

Transform compliance from a burden to a business advantage.

Add-Ons

Postmarket
Supplier
Regulatory
Clinical
Data & Analytics
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Pricing

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ROI Calculator
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Manufacturing

Manufacturing Excellence Suite

Manufacturing Excellence Overview

Boost operational efficiency and ensure quality at every step with an intelligent suite of products built for regulated industries.

Device History Records (eDHR)

Digitally managed device history records simplify submissions, improve compliance, and accelerate product release.

Manufacturing Execution System (MES)

Gain real-time visibility and control into your production operations to drive efficiency, reduce waste, and speed delivery.

Electronic Logbooks

Ditch the paper to boost data accuracy, increase accountability, and reduce bottlenecks when tracking routine activities.

Batch Records (EBR)

Eliminate batch record errors and increase throughput with fully digital, compliant documentation.

Add-Ons

Data & Analytics
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Pricing

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ROI Calculator
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Asset

Asset Excellence Suite

Asset Excellence Overview

Centralized, compliant asset tracking that simplifies lifecycle management, increases equipment uptime, and safeguards long-term performance.

Commercial Calibration Management

Deliver faster, more reliable service and ensure customer satisfaction with automated scheduling, real-time tracking, and a collaborative client portal.

Equipment Calibration

Gain instant visibility into tools, work orders, and technician schedules without increasing administrative burden.

Regulated Asset Management

Gain complete control over instruments and equipment to boost compliance, extend asset lifespan, and simplify audits.

Equipment Maintenance

Maximize asset lifespan and minimize downtime with real-time insights and usage-based triggers that optimize equipment performance.

Computerized Maintenance Management (CMMS)

Integrate maintenance, calibration, and asset data into one platform to improve efficiency and regulatory compliance.

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Pricing

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Industries

Industry Solutions

Pharmaceuticals

Quality management and manufacturing solutions for pharmaceutical industry success.

Blood, Biologics and Tissue

Advanced quality control solutions for blood, biologics and tissue management.

Contract Manufacturing

Contract manufacturing solutions for life sciences: flexible, quality-focused production management.

Medical Device

Optimize medical device manufacturing compliance, quality control and regulatory approvals.

Food and Beverage

Digital solutions for food and beverage quality, safety and compliance.

Government

FedRAMP-ready QMS solutions for government life sciences agencies

Dietary Supplements

Enhance supplement production with automated quality and compliance controls.

Cell and Gene Therapies

Optimize cell and gene therapy production with secure, compliant, and flexible digital solutions.

Lab Management

Innovative solutions that simplify compliance and help lab operations teams focus on their research.

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Pricing

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Resources

Resources

Resource Center

White Papers, Videos, Guides and more. Our industry expertise is yours.

Blog - GxP Lifeline

Read our newest articles from our industry experts.

Events

See thought leaders sharing helpful insights and best-practices for manufacturing in highly regulated industries.

Partners

Grow your market and revenue with a MasterControl Partnership.

Glossary

Look up key quality manufacturing terms.

Compliance

Explore compliance solutions and resources to navigate regulatory requirements in your industry.

Topics

CAPA Software
Deviations Management
Nonconformance
Out of Specification
Manufacturing Traveler
Recipe Management
Variant Management
Digital Work Instructions
Review by Exception
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US

Americas

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Europe

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Asia Pacific

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Glossary

MasterControl Glossary

Industry Terms and Definitions

21 CFR Part 11
21 CFR Part 210
21 CFR Part 211
21 CFR Part 58 — Good Laboratory Practices (GLP)
21 CFR Part 820
29 CFR 1910.1450 — OSHA Laboratory Standard
Annex 11
Asset Lifecycle Management (ALM)
Audit Management
Batch Manufacturing Record
Cell and Gene Therapy (CGT) Manufacturing
Change Control Management
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