21 CFR part 11 validation for SAAS

Posted by javydreamercsw on Stack Overflow See other posts from Stack Overflow or by javydreamercsw
Published on 2010-02-23T23:13:17Z Indexed on 2010/05/21 20:00 UTC
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validation

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saas

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regulation

In a FDA regulated environment applications need to be validated. I've done that tons of times in my career but now I'm facing SAAS. Has anyone out there faced this before? Any FDA related guideline on this scheme?

Besides some black box approach and much support from the provider I see this as hard to do.

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