on 09-09-2014 3:49 PM
Hi,
We are working with ME 6.0 (ME 15 in the future).
We have now a requirement to validate ME. I believe we are talking about following: EU GMP annex 11, FDA part11, GAMP, etc. I do not even know what is required but can someone tell me if ME system validation has been done?
Br,
Pete
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