Oktay Olcum has over 20 years’ of experience in validation and qualification activities within the cGMP regulated Pharmaceutical Industry.

 

He has supervised and organized computer system validation and qualification activities in laboratories and production areas, as well as purchased, implemented, and maintained computerized systems and equipment for maximum efficiency and accuracy. 

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Olcum possesses experience in FDA, MHRA, and EU inspections on electronic data integrity and computer systems validation/qualification activities and has created validation master plans and SOPs for CSV according to current regulations, predicate rules, and GAMP5 guidelines.