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FDA System

MasterControl has a compliant FDA system for all FDA-regulated companies to maintain their own quality and regulatory systems.

MasterControl, a software company, allows FDA regulated companies to streamline document control, audit management and process management across departments and geographical boundaries with an FDA system for compliance and higher quality products. To learn more about achieving FDA compliance with MasterControl's web-based solutions, please feel free to download the following material:

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White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments
White Paper: Noncompliance to FDA Quality Standards: What's the Risk to Executives?
White Paper: The Future of the FDA: Operating in an Electronic World
White Paper: The Value of Studying and Utilizing FDA's QSIT Manual
White Paper: FDA Inspections of Clinical Investigators: Are You Ready?
Product Data Sheet: MasterControl Suite Overview
Demo Video: MasterControl Quality Management System (QMS) Overview

Compliant FDA Systems

The FDA itself uses many systems to organize the information necessary for the safety of consumers. These systems, whether designed to streamline submissions management, audits, or postmarket approval processes, are designed to keep the FDA organized. Likewise, the FDA requires that FDA-regulated companies maintain their own systems. These compliant FDA systems include training, complaints management, document management, change control, nonconformance events, deviations and CAPA systems. MasterControl provides the solutions that allows these companies to streamline and integrate these processes and improve company document control, collaboration and communication between departments.

MasterControl provides the following solutions for regulated companies needing FDA systems:

  • MasterControl Documents™
  • MasterControl Process™
  • MasterControl Audit™
  • MasterControl Deviations™
  • MasterControl Nonconformance™
  • MasterControl Change Control™
  • MasterControl CAPA™
  • MasterControl Training™
  • MasterControl Submissions Gateway™
  • MasterControl Submissions Locker™
  • . . . and more!

MasterControl FDA System Validation

In addition to making it easier for regulated companies to comply with the regulations of a FDA system, MasterControl also provides validation solutions, tools and services that can save life science companies significant amounts of time and revenue.

For More Information on FDA Systems

For more information in regard to having a compliant FDA system, please feel free to contact a MasterControl representative.