Over 500+ 5-Star Reviews

Modernize With Electronic Document Control

Keep up with regulatory mandates to modernize data practices.

Regulatory agencies are keen to see medical device manufacturers update and secure their document management practices in order to make their processes more efficient and their products safer. Cloud-based document control software makes this possible. You can automatically maintain version control and eliminate the need for in-person meetings to complete drawn-out review and approval cycles.  

With MasterControl’s document control system you can easily:

  • Store all documents in a secure, centralized repository.
  • Let authorized users simultaneously access and mark up documents.
  • Give team members access to documents anytime and from anywhere.
  • Designate alternate reviewers.

Awarded #1 Quality Management System in the Life Sciences

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Dive into a world where compliance, efficiency, and quality converge seamlessly

Digital Document Management

Change Control

Training and Exams

Quality Events and CAPA

Compliance and Audit Management

Risk Management

Data Analytics and Insights

Document Control Software

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.

  • 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
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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

MasterControl’s quality risk management software for the medical device industry.

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
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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.
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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
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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
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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)
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Choose Compliant Document Control Software

You can choose from an array of digital document control systems, but not all systems are created equal. If you want to remain an industry leader, your solution should give you true electronic document control. This means you can easily store and access the latest version of documents from a centralized repository, eliminate data silos and errors, and expedite necessary document changes. You can also approve, track, and verify all necessary changes according to regulations to be audit-ready all the time.

  • 1,100 +

    Customers

  • 850 K

    Users

  • 30

    Years Serving Life Sciences Companies

  • 43

    G2 Awards for Summer 2024

  • 36

    Countries with MasterControl Customers

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!

Sign Up For The Demo Now!
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