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GMP Guidelines

MasterControl Inc. helps regulated companies automate, streamline, and effectively manage document and quality control so they can comply with GMP guidelines.

GMP guidelines set forth by the FDA work to ensure the safety and quality of natural science products. MasterControl Inc. helps regulated companies automate, streamline, and effectively manage document and quality control so they can comply with GMP guidelines.

About MasterControl Inc.
MasterControl Inc. is a leading global provider of GxP process management software that was specifically designed to meet the needs of natural science companies regulated by the FDA and EU. With an integrated software system and time-tested technical and customer services, over 400 companies around the world choose to employ MasterControl software systems.

Achieve Regulated Compliance with GMP Guidelines
MasterControl Inc. takes pride in being a software provider that goes beyond software to provide real solutions to the everyday challenges of compliance. MasterControl suite is an integrated, easy to use GxP process management software system that helps companies attain and sustain compliance with GMP guidelines. The following applications are included in the complete software system:

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

:Implementation, Validation, and Product Training Services
GMP guidelines require that GxP process management software systems follow certain steps when it comes time to implement and validate software. With years of industry experience, MasterControl has developed time-tested implementation and validation methods to help companies deploy software sooner and achieve software ROI faster.

    • Implementation Services: include database creation, installation, and configuration.
    • Validation Services: comply with GMP guidelines and 21 CFR Part 11 to ensure continuous validation. These services include full-cycle validation, validation toolkit, and continuous development.

    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




      For More Information
    Compliance with GMP guidelines and EU regulations is part of doing business in most industries, but especially in the natural science industry. MasterControl’s Resource Center provides regulated natural science companies with the educational and research materials they need to make important decisions. Industyr white papers and the other Resoruce Center materials provide information about GMP guidelines, EU regulations, and industry current events.

    To learn more about GMP guidelines and the software solutions that help companies sustain regulatory compliance, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

    Related Items:

    • GMP
    • CGMP
    • GXP
    • GMP Regulation
    • Internal Audit Reporting
    • Market Regulated
    • Serious Adverse Event
    • Assurance Quality Tool
    • Change Management Procedure
    • Compliance Document


Online Demos & Recorede Presentations
GxP Lifeline

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


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