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09104 - FDA regulations regarding software validation

09104 - FDA regulations regarding software validation

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FDA regulations regarding software validation

I'm installing support packages in our production system this weekend, and the
organization's Quality Assurance Manager says that he needs descriptions of
'What is a Support Package and Why We Need to Install Them' in case the FDA
(Food and Drug Administration for my overseas friends) comes in to do a system
audit. (I'm at a company that makes bio-medical supplies and they are closely
audited to ensure quality of product, processes, and systems).

I searched SAPNet and can't find any white papers from SAP describing the
benefits of Support Packages and staying current, just the occasional paragraph
describing support and explaining fixes and enhancements.

Does anyone have a document they could share that describes (non-technically)
why we apply support packages to an R/3 system?

Thanks!


Catherine Paalvast
Basis / iSeries Consultant
AMS Systems Integration
cpaalZams-partners.com

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