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GMP Guidelines

MasterControl Inc., a GxP process management software provider, helps regulated companies employ the software solutions they need to sustain compliance with GMP regulation year after year.

GMP regulation is set forth by the FDA to guide the quality and safety of natural science products. MasterControl Inc., a GxP process management software provider, helps regulated companies employ the software solutions they need to sustain compliance with GMP regulation year after year.

About MasterControl Inc.
MasterControl Inc. is a leading global provider of GxP process management software specifically designed to meet the unique needs of natural science companies competing within the rigorous FDA and EU environements. With over a decade of experience, MasterControl knows just how challenging regulatory compliance with GMP regulation can be. Their GxP process management software helps companies stay compliant, connected, and complete.

Comply with GMP Regulation with MasterControl’s GxP Process Management Software
MasterControl’s GxP process management software offers an integrated, easy to use approach to compliance with GMP regulation compliance. MasterControl software goes beyond software to offer real solutions to every day compliance challenges. With MasterControl suite, FDA and EU regulated companies can find software solutions to automate, streamline, and effectively manage change control, document control, employee training, CAPA, customer complaints, Sarbanes-Oxley Act requirements, and more. MasterControl suite includes the following continuum of configurable software applications:

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

:Time-Tested Implementation and Validation Methods
GxP process management software is guided by GMP regulation just as the manufacturing process of natural science products are regulated. With years of industry specific experience, MasterControl has developed time-tested implementation and validation methods to help companies deploy software sooner and receive software ROI faster.

    • Implementation Services: MasterControl combines industry best practice GMP regulation with unique customer requirements to provide optimized GxP process management software. MasterControl works alongside their customers’ IT Department to provide the implementation services, which include database creation, installation, and configuration.
    • Software Validation Services: 21 CFR Part 11 and GMP regulation, include requirements to validate electronic record keeping systems. MasterControl provides full-cycle validation, a validation toolkit, and continuous development to help companies comply with industry best practices.

    Downloads - GMP Training

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

    Product Data Sheet:
    MasterControl Training
    White Paper Download:
    21 CFR Part 11 - Risks of Noncompliance




      Questions? Contact MasterControl Online
    GMP regulation guides the quality and safety of natural science products. To learn more about GMP regulation and MasterControl’s software solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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   800-825-9117


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