FDA responses to questions regarding the use of cloud-based software in clinical trials. Click here to access the full library of FDA responses to GCP questions regarding electronic processes in clinical investigations.
What are the requirements/guidance on cloud-based servers?
There are none. As of right now, the FDA has not addressed cloud-based servers. Both the software vendors and end-users should take the recommended steps to validate the software’s use in the end user’s computing environment (from 2016). Documentation in library.
Are cloud storage systems secure enough for storing clinical trial data?
The sponsor/CRO (if sponsor transfers obligations to the CRO) should determine if the cloud storage system is secure enough since the FDA has not published any guidance on cloud storage yet (from 2016). Documentation in library.
Does the FDA consider it acceptable for data to be distributed across a cloud computing service’s hardware at several different geographic locations at the same time without being able to identify the exact location of the data at any given time?
Yes as long as appropriate controls are in place (from 2017). Documentation in library.
Click here to access the full library. The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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