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Shilpa Desai

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Latest trends in software validation

There is a need to follow strict documentation with Document Control, SOPs, etc. with their audit histories for them to comply with GxP. As it is a regulatory requirement, we, as software vendor, we have tried to incorporate SOPs and have reviewed and modified them as time has gone by…
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What is Software Validation?

As per US FDA’s 21 CFR Part 11 compliance requirements, software validation is a key task. And a lot of material is available over the net on this topic. But my take on software validation is something like this…
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