FDA Requirements

MasterControl Inc. helps companies comply with FDA requirements and ISO quality standard with easy to use, cost effective software solutions.

FDA requirements and ISO quality standards guide the way regulated life science companies do business on a daily basis. These companies must comply with quality standards in order to ensure that the products they offer are both safe and of the highest quality. MasterControl Inc. helps companies comply with FDA requirements and ISO quality standards with easy to use, cost effective software solutions.

Free Downloads

White Paper: 21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?
White Paper: Effective Nonconformance Management Key to FDA and ISO Compliance
White Paper: Automating Training Control Processes
White Paper: Automating Document Control Processes
Q&A: The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?
Product Data Sheet: MasterControl™ Solutions Overview


Watch Videos

Using MasterControl for FDA Compliance (3:53)
Improving Quality with MasterControl (2:59)

About MasterControl Inc.

For over a decade, MasterControl Inc. has been at the forefront of the GxP process and document management software solutions industry. As the first company to provide a software solution that specifically addressed FDA requirements and ISO quality standards, MasterControl Inc. has the industry experience regulated companies need to comply with current industry best practices and maintain an FDA approved status.

Comply with FDA Requirements Year after Year

MasterControl's GxP process and document management software solution, MasterControl suite, is an integrated, easy to use approach to compliance with FDA requirements. MasterControl's software solutions include a continuum of configurable applications that regulated companies can choose to deploy based on the unique needs of their company and the industry in which they compete. These FDA compliant applications include the following:

  • MasterControl Documents
  • MasterControl CAPA™
  • MasterControl Training™
  • MasterControl Forms™
  • MasterControl Change Control
  • MasterControl Audit
  • MasterControl Customer Complaints™
  • MasterControl Nonconformance™
  • MasterControl SOX™
  • MasterControl Submissions Gateway™

For More Information

It is imperative that regulated companies know the FDA requirements and regulation that guides their industry. MasterControl's Resource Center is a comprehensive site dedicated to providing regulated companies with the educational and research materials they need to learn more about FDA requirements, industry current events, and quality management systems. Companies can find the following materials:
  • Product Data Sheets
  • Industry White Papers
  • Tech Papers
  • Case Studies
  • Q&As
  • Online Demonstrations

Questions? Contact MasterControl Today

Complying with FDA requirements year after year is a challenge. To learn how MasterControl's GxP process and content management software solution helps companies around the world comply with FDA requirements, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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