About MasterControl - Being FDA Approved
Since 1993, MasterControl Inc. has assisted regulated companies throughout the world as they strive to obtain and maintain compliance with FDA approved processes and ISO regulations. The Salt Lake City, Utah-based company was the first GxP management firm to directly address the compliance challenges of the FDA's 21 CFR Part 11. For more information about MasterControl's corporate background, click here.
Maintaining FDA Approval
MasterControl has developed revolutionary quality management software that is expressly designed to meet the unique FDA approved compliance needs of regulated companies in life science fields such as:
- Medical Devices
- Contract Organizations
MasterControl FDA Approved Compliance Solutions
MasterControl's quality management system effectively and efficiently controls documents and quality in one integrated, user friendly system. The MasterControl suite includes the following applications to achieve FDA approved status:
- MasterControl Documents™
- MasterControl CAPA™
- MasterControl Deviations™
- MasterControl Change Control™
- MasterControl Training™
- MasterControl Nonconformance™
- MasterControl Audit™
- MasterControl Customer Complaints™
- MasterControl Forms™
- MasterControl Submissions Gateway™
- MasterControl Electronic Batch Records
- MasterControl Equipment Calibration™
- MasterControl Equipment Maintenance™
- . . . and more!
The MasterControl suite provides sustained compliance, integrated quality management and enterprise-wide product application to help companies stay FDA approved. The features provided by the integrated MasterControl solution make it possible for customers worldwide to comply with current good clinical practices (CGCP), current good laboratory practices (CGLP), and current good manufacturing practices (CGMP).
The MasterControl Resource Center showcases case studies that illustrate the role of MasterControl in helping regulated companies maintain FDA approved status. The Resource Center also has other complimentary educational and research materials, including:
- Product Data Sheets
- White Papers
- Tech Papers
- Online Demonstrations
- Industry News
Questions About FDA Approved Systems? Contact MasterControl
Achieving FDA approved status is a process, not an event. The MasterControl team is here to provide answers and help your regulated organization get FDA approved. To learn more, call toll free at 1-800-825-9117 or contact us.