Validation Of Cloud Hosted EDC Systems

What experiences do CTUs have of validating EDC systems that are cloud hosted?

This assumes that the vendor is contractually responsible for the validation and were audited as part of the selection process.

I am particularly interested in what level of validation is undertaken by CTUs at the initial stage and then after regular updates.  Are updates mandatory or do you have a choice?

Thanks

Amanda Bravery

Head of ICT, ICTU

Imperial Clinical Trials Unit| School of Public Health| Imperial College London

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