FDA Compliance Software

MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realize FDA compliance with their quality management systems.

Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

About MasterControl's FDA Compliance Software

Since 1993, MasterControl Inc. has been at the forefront of the FDA compliance software industry providing time-tested solutions to real FDA and ISO compliance challenges. MasterControl was the first QMS provider to provider a software system that directly addressed FDA and ISO regulations.

FDA Just Called! Now What?


MasterControl's FDA Compliance Software

MasterControl takes pride in offering FDA compliance software that goes beyond software to offer real solutions to real compliance challenges within the FDA and EU regulatory environments. With MasterControl suite, FDA and EU regulated companies can document, track, and effectively manage all of their document management processes. MasterControl quality management suite includes the following integrated, easy to use applications:

  • MasterControl Documents™
  • MasterControl CAPA™
  • MasterControl Deviations™
  • MasterControl Change Control™
  • MasterControl Training™
  • MasterControl Nonconformance™
  • MasterControl Audit™
  • MasterControl Customer Complaints™
  • MasterControl Process™
  • MasterControl Submissions Gateway™
  • MasterControl Supplier™
  • MasterControl Projects™
  • MasterControl Bill of Materials™
  • Plus More!

Implementation, Training, and Validation of FDA Compliance Software

With more than a decade of experience, MasterControl has developed the customer and technical support that goes beyond FDA compliance software. MasterControl's time-tested implementation, training, and validation services help companies employ FDA compliance software sooner and realize software ROI faster.

  • Implementation Services: MasterControl works with their customers IT Department to employ the implementation phase, which includes database creation, installation, and configuration.
  • Product Training Services: MasterControl's Professional Services team, consisting of former FDA experts and IT system administrators, conducts product training at the state-of-the-art Training Center in Salt Lake City Center or at their customers' facilitates. FDA compliance software training services include system administration training, validation, onsite training and configuration, coaching program, and advanced training.
  • Validation Services: MasterControl's Professional Services team has a variety of industry backgrounds to help you meet the FDA compliance software validation requirements. They can help with validation project planning, procedure development, protocol development, systems audits, and third-party review of documentation. We can provide the IQ, OQ, PQ, and TOQ templates and services necessary to quickly validate your MasterControl system.

Questions About FDA Compliance Software? Contact MasterControl Today!

It is time to implement a truly robust and dynamic FDA compliance software system. To learn more about MasterControl's complete approach to FDA compliance software, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.