The stringent regulations for establishing, implementing, and maintaining compliance with Current Good Clinical Practice (cGCP) regulations can seem daunting. Companies face many challenges in controlling required documentation during all clinical phases. With MasterControl the process of satisfying the compliance requirements for cGCP can become an easily manageable part of corporate culture.
For more than two decades, MasterControl has provided configurable and easy-to-use quality management software solutions that keep companies connected and properly aligned with cGCP requirements, like 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.
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Meeting the full requirements of cGCP in an efficient manner entails that companies establish and maintain compliant, connected, and complete clinical quality systems.
For more information about cGCP requirements and how MasterControl can help your organization achieve and sustain compliance according to the FDA-established cGCP guidelines, please feel free to contact aMasterControl representative.