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Digital Document Management
Your documents should be digitized and available anytime, anywhere. MasterControl's QMS utilizes cloud architecture and a secure system to digitally vault and manage documents.
Over 500+ 5-Star Reviews
A QMS Designed for ISO Compliance
Find out how ISO-certified organizations optimize their QMS to ensure high-quality products and continuous compliance.
If your quality infrastructure is lacking, you’re not equipped to meet the requirements that compliance with International Organization for Standardization (ISO) standards demands. Robust digital quality management system (QMS) software like the proven MasterControl Quality Excellence solution can provide the foundation you need to maintain compliance with auditing management standards such as ISO 19011, quality management standards like ISO 16949, and other crucial ISO standards.
- Learn why precise adherence to approved policies and procedures is key to ISO compliance.
- Discover how a digitized QMS improves collaboration, communication, and efficiency.
- Find out why changes are inevitable in ISO environments – and how you can control them more effectively.
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Awarded #1 Quality Management System in the Life Sciences
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Trusted By 1,100+ Companies Worldwide
Recent G2 Awards
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Dive into a world where compliance, efficiency, and quality converge seamlessly
- Organize documents automatically
- Collaborate on documents virtually
- Automatically launch training tasks
- Securely share documents outside of your organization
- Remain audit-ready and 21 CFR Part 11 compliant
Change Control
Take control of change control with tools that help you handle policies, work instructions, engineering change, and more.
- Digital signature and approval workflows
Change control, revisions, versioning, and automatic archiving
Automatic training tasks when documents change
Audit trail for regulatory compliance
Training and Exams
MasterControl's training management software greatly improves your employee training program. It automates all training tasks, from routing and tracking to follow-up and escalation.
- Automatic routing, tracking and follow-up
- Connected documents and automated processes
- Audit-ready records
- Maintain and prove regulatory compliance
Quality Events and CAPA
MasterControl puts you in control of quality events. Our latest advanced quality event management solution literally puts the power to design, build, and automate processes - as well as analyze quality event data - in the hands of quality professionals.
- Use our best-practice templates or create your own custom processes - no coding needed.
- Simplify complex processes and bring logic to quality events.
- Increase efficiency with email notifications, in-app notifications, and actionable tasks lists.
Compliance and Audit Management
Add tools to your processes that make it easier to plan and prepare for internal and external audits.
- Schedule audits with drag-and-drop calendaring
- Guest Connect streamlines auditor feedback
- Connected platform for sharing documents and launching events
- Create reusable audit templates and standards
Risk Management
Get your products out the door successfully and avoid added costs with tools that help you assess and manage risks.
- Visibility into risk-related activities
- Configure and evaluate multiple risk types
- Tracking and analysis for identifying and mitigating risks
- Launch assessments within the MasterControl system
Data Analytics and Insights
Get the most out of all the critical information produced by your QMS by turning that data into actionable business intelligence.
- Capture and structure data effortlessly
- Configure and evaluate multiple risk types
- Easily create customized, interactive dashboards
- Explore smart insights (AI-powered automatic insight generation)
A Name Companies Trust to Help Meet ISO Standards
When it comes to helping companies manage quality effectively and efficiently, MasterControl has been a trusted name more than 25 years. Our QMS is an essential tool for companies seeking to consistently meet regulatory requirements such as those outlined in standards like ISO 10993, ISO 11607, ISO 60601, ISO 10993, ISO 16949, ISO 17025, ISO 15485, ISO 19011, and many more ISO, FDA, and other standards and regulations.
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1,100 +
Customers
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850 K
Users
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30
Years Serving Life Sciences Companies
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43
G2 Awards for Summer 2024
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36
Countries with MasterControl Customers
Learn More about MasterControl's QMS Software
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MasterControl's Quality Management System
Ensures compliance, lowers risk, accelerates timelines, and improves speed and quality while reducing costs. Don't just keep up with the industry—lead it confidently into the future.
Ready to revolutionize your Life Sciences operations?
Take the first step by signing up for a demo. Your journey to unparalleled excellence starts here!
