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FDA Requirement

MasterControl Inc. is a leading provider of document and process management systems specifically designed to address the compliance needs of natural science companies seeking compliance with FDA requirement.

FDA requirement regulates the natural science industry to ensure the quality and safety of the products that matter most to—pharmaceuticals, medical devices, biotechnology, and more. MasterControl Inc. is a leading provider of quality management systems specifically designed to address the compliance needs of natural science companies seeking compliance with almost any FDA requirement

About MasterControl Inc.

MasterControl Inc. is a global provider of GxP process and document management software solutions, helping regulated companies within the natural science industries attain and sustain compliance year after year. With years of industry specific experience and a dedication to providing comprehensive technical and customer services, it is no wonder of 400 companies around the world choose MasterControl solutions to comply with FDA requirement.

White Paper Downloads - FDA Requirements

White Paper Download:
Automating Training Management and Training Control Processes in FDA and ISO Environments

Product Data Sheet:
Automating Document Control Processes in FDA and ISO Environments
White Paper Download:
FDA 21 CFR Part 11 - Risks of Noncompliance



Achieve Sustained Compliance to FDA Requirement

MasterControl takes pride in being a software provider that goes beyond software. MasterControl suite is an integrated, easy to use GxP process and document management software solution specifically designed to address FDA requirement and EU regulation in the natural science industry. With a continuum of fully configurable applications, MasterControl suite keeps companies compliant, connected, and complete. These 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™


Time-Tested Implementation and Product Training Services

With more than a decade of experience, MasterControl has developed time-tested implementation and product training services to help regulated companies ensure compliance with FDA requirement sooner with faster software deployment and ROI.

  • Implementation Services : most companies assign their key document and quality control or regulatory affairs personnel to learn MasterControl suite in depth. MasterControl's Technical support team guides their personnel through database creation, installation, and configuration.
  • Product Training Services : MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, developed the comprehensive product training program, which includes system administration training, onsite training and configuration, coaching program, and advanced training options.


Questions? Contact MasterControl Today

Complying with FDA requirement is challenging, but it is possible. To learn how MasterControl's GxP content and process management software solutions help natural science companies around the world comply with FDA requirement, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

Related Items:

  • Compliance FDA Software
  • FDA Inspection
  • FDA
  • Corrective Action Form
  • Audit Checklist
  • Audit Management Software
  • Database Document Management
  • Employee Training Software
  • Implementing Total Quality Management,


Online Demos & Recorede Presentations
GxP Lifeline

    Call us for a free consultation:
   800-825-9117


Why is MasterControl the Right Software Solution for Your Industry?

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