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Validations required with the Enterprise addition

We currently have the Enterprise addition of OpenClinica. I’m curious how other companies with the Enterprise addition handle validations. Do you run your own validation in addition to everything that OpenClinica provides to you for new Enterprise releases? If so what types of validations are you running? Do you run validations on all new study builds in OpenClinica? If so what are they? We are getting ready to start an IDE study and there have been some discussions about what validations are needed in order to be compliant. I’d also like to upgrade before starting the IDE but have been holding off for fear of a lengthy internal validation. Any insight would be greatly appreciated.


  • abertuzziabertuzzi Posts: 51
    The question you rise is very interesting.
    Here is my contribution:

    OpenClinica provides detail of the specifications and evidence of the results of the tests they make before releasing the sw through the so called "Regulatory Support Package", document they set available to subscribers of the Enterprise Edition each time a new version is released.

    As users of the software for our projects, we validate it through a typical process that among other aspects includes the definition of our set of user requirements and testing.

    Validation testing include operational qualification testing of the most critical functions (or of the new/modified features relevant to us included in a new version). Evaluation of extent and results of the functional testing executed by OpenClinica (documented in the "Regulatory Support Package") allows us to decide the extent of the tests we need to execute to obtain confidence of the correct software performance.

    Part of the initial validation is also a performance qualification test in which the entire data definition-collection-review-extraction process is verified according to the way we intend to use the software.
    (Each sw installation on a different computer system is obviously verified through a dedicated "installation qualification" testing executed by the installer).

    While the above described process covers the validation of the basic functional features of the sw, a different process is dedicated to the study configuration, i.e. the set of CRFs, rules and scripts for data collection that are implemented for a defined clinical study.
    Each time a new study is implemented, the specifications of forms, data items, data validation checks, required automation features are defined and, before the study is released to production, are tested following a specific test protocol to ensure the study configuration performs as expected.

    I hope many others will add their experience.
  • kristiakkristiak Posts: 1,340 ✭✭✭
    My contribution is slightly different. We work mainly with hospitals and universities with very limited resources and thus cannot afford the Enterprise version. Thus we have created our own validation process as you will find the index paid attached. Hope it can help others as well.
  • kristiakkristiak Posts: 1,340 ✭✭✭
    Sorry, my proofreading. should be "index page"
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