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OC Complaince and validation

We are running the community version of Open Clinica
However our monitors have asked whether the software is
1) Validated
2) FDA compliant

Could you be having any response to this


  • tkhajatkhaja Posts: 62 ✭✭
    Hi Kayoub,

    Both the community and the enterprise versions of OpenClinica are validated prior to the release. Please note, if you purchased the enterprise edition then we will also validate your environment by running a qualification report once the installation is complete.

    We do know that some of our customers have submitted their studies to the FDA and are currently running some for FDA submissions.

    Finally, if you purchase the Regulatory support package, you will get access to the
    release validation documents and much more.

    Let me know if you have further questions.

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