44. Cloud Validation – FDA Part 11 Challenge for IaaS

Regulators agree that you can outsource services, but they insist that you cannot outsource your GXP responsibility. (p. 160)   Cloud technology for Infrastructure as a Service (IaaS) and Platforms as a Services (PaaS) must comply with US Food and Drug Administration (FDA) law 21 CFR Part 11 Electronic Record Keeping; Electronic Signatures. Referred to…