FDA Approved

MasterControl Helps Regulated Companies Maintain FDA Approved Status

The shared goal of regulated life science companies is to first achieve FDA approval and, ultimately, to preserve that FDA approved status. On the forefront of the document management industry, MasterControl Inc. provides content management solutions to over 400 regulated pharmaceutical, medical device, and biotechnology organizations around the world, sustaining their ability to stay FDA approved. MasterControl goes beyond software by providing functional solutions that allow companies to comply with best practice guidelines and regulations like FDA 21 CFR Part 11. 

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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:

  • 医薬品
  • 医療機器
  • バイオテクノロジー
  • 血液/組織
  • 研究所
  • 受託機関

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's Resource Center

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:

  • プロダクトデータシート
  • ホワイトペーパー
  • ケーススタディー
  • Q&A
  • オンラインデモ
  • 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.