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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.