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Besides the necessary documentation for use and maintenance that is supplied as integrated part of the system, TECNinox supplies, upon customer’s request, a validation protocol issued in accordance with cGMP and GAMP standards.

A group of specialists takes care only of this department in order to set up all design and operational plant specifications and all necessary test cards to carry out all inspections during FAT/SAT.

Documents such as QPP, RA, FS, HDS, SDS, IQ/OQ and alsoPQ are issued carefully and in continuous partnershipwith the customer.

Documents for plant qualification TECNinox
Documents for plant qualification TECNinox
Documents for plant qualification TECNinox
Documents for plant qualification TECNinox