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?
Not to perform the OQ verficcation activities but we did use a off-shore team in to perform some development work for a Pharma application.
There were advantages (cost) and disadvantages (quality of work was questionable as times) so I would go into it with open eyes.
I know who have estimated that there will be a 50% saving but ensure that the team understands the level of work they need to produce. In the long run the 50% saving may end up costing you more.
Having the documents sent electronically is fine, I am actually involved with a FAT at the moment where the documents are been executed in the states and then PDF’d over for review.
A few points: make sure all the deviations and discrepancies get send over too, and any other applicable documentation.
Also make sure your contact over there will be available if you need anything else sent over or you need anything clarified.
One other point, might be a good idea to send over a sample of the quality of work that you expect and ensure that all executors over there have GDP training and any other training that is required.
