42. Cloud Validation – Technology Challenges

42. Cloud Validation – Technology Challenges

IQ and Configuration Management …there is no IQ visibility into the platform and no control over the location of the data on the cloud infrastructure. (p. 160)   Software as a Service (SaaS) applications used in a GXP regulated work process still require end user validation to FDA Part 11 and EU Annex 11 standards.…

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