Good Clinical Practice (GCP) Compliance

MasterControl's Good Clinical Practice (GCP) Compliance Software for Assuring GCP Compliance

The regulations for establishing, implementing, and maintaining GCP compliance can be overwhelming. Companies face many challenges in controlling required documentation and managing processes during clinical studies. With MasterControl, the processes involved in satisfying GCP compliance requirements can be simplified and streamlined.

MasterControl Clinical Quality Management System (CQMS)™

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For more than a decade, MasterControl has provided configurable, easy-to-use quality management software solutions that keep companies’ clinical quality processes connected and properly aligned with the most current GCP compliance requirements, such as the ICH GCP E6 R2 Addendum, which encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

Meeting the Requirements of Good Clinical Practice (GCP) Compliance

GCP compliance requires companies to be compliant, connected, and complete.

  • Compliant: Through automated quality business processes, MasterControl helps companies attain GCP compliance and sustain it year after year. MasterControl also provides the resources companies need to validate and maintain their software solution.
  • Connected: MasterControl connects users with the data and processes needed to see the "big picture" of clinical quality. MasterControl’s holistic approach facilitates collaboration and allows managers to view and monitor all clinical quality processes in real time.
  • Complete: MasterControl helps companies realize GCP compliance as a part of their everyday corporate culture, so every department across the enterprise can be assured that compliance is being maintained.

For More Information About Good Clinical Practice Compliance

For more information about GCP compliance, and how MasterControl can help your organization achieve and sustain good clinical practice compliance according to the FDA's rulings on GCP guidelines, please feel free to contact aMasterControl representative.