43. Cloud Validation – Safe Harbor Challenge

43. Cloud Validation – Safe Harbor Challenge

Regulators agree that you can outsource services, but they insist that you cannot outsource your GXP responsibility. (p. 160)   Software as a Service (SaaS) applications used in a GXP regulated work process still require compliance to EU Privacy Directives and to US Health and Human Services (HHS) legislation known as the Health Information Portability…

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