Compliance and Validation for Software-as-a-Service

Conflicting and, in some cases, minimal details and insight from the FDA have caused confusion within the industry with regard to Computer System Validation. Industry standards such as GAMP 5 have emerged, but questions regarding validation continue. What about validation of Software as a Service (SaaS) solutions? What is the concept of solutions that are indicated as “pre-validated” by a vendor? These and similar questions occur frequently during compliance conversations within the industry

This white paper will define the most efficient validation strategy for SaaS solutions and try to answer frequent questions raised around the topic.

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