We are currently developing a MES (Manufacturing Execution System) which will be used in a regulated environment. I am managing the System Testing and OQ verification activities. I need to build a team of resources to perform these tasks.
Question for all you experts out there
Has anyone used off shore teams, ie. Teams in India, Ukraine, Eatern Europe to perform OQ. We would be following the GAMP5 approach where we would leverage our OQ verification activites through the documented functional testing we would be doing during system testing.
How would the OQ documentation work if we were to have the documents sent electronically from scanned originals and then the Software QA Manager (myself) sign these copies locally?
Cost is about 50% of having it done locally.