[quote=maryacton]All Experts,
I have worked as a CSV validation team member on a few SCADA systems, lab systems and network validation projects. Now, I am being assigned to the SAP team as a validation representative. But I have only a general idea on how SAP systems work and what one needs to look for in terms of SAP Validation
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. Can anyone provide me any reference documents/articles/materials on the net or a book that can :
help me in understanding the SAP systems in general quickly.
guideline on what one needs to be looking for and in what modules in terms of validating SAP systems in a regulated environment.
Your help is greatly appreciated!
Thanks![/quote]
Wonderful! thanks for the info that you guys have been discussing. Awesome!!!
Which SAP is the world’s largest developer to reduce costs and increase productivity to help many drug companies are information technology and enterprise resource planning software turns.
But will SAP or any new ERP system must be an intensive validation according to FDA regulations pass. And it is important that you know what the FDA expects. It is much more than you expert advice, planning, it is every step to ensure their integration and implementation meets FDA requirements.
And right here, where you learn everything you need to know you see how the necessary steps to "leak"plug and assure an airtight validation effort required.
Involved in a validation and qualification SAP project, we have Prototype, DEV, QAS and Prod. Does development need to be qualified? We usually only qualify QA and Prod in other systems. Please advise.
I have a question related to SAP validation. I have been asked to validation SAP according to FDA regulations. The company do not want me to do a complete SAP validation. I am new to ERP system validation, never done SAP validation before, so how do I build a general test strategy for it. I mostly have to keep in mind 21 CFR part 11. they dont want a very heavy documentation too. Just some relevant testing.