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Frederik Winther Andersen

Consultant

Data Integrity
GMP
Risk Management
Computer System Validation

Frederik Winther Andersen is a consultant with a background as a mechanical engineer. During his education and more than four years of experience he has gained a solid knowledge of machines including assembly-, labeling- and packaging machines. Frederik has also worked on several projects with implementation of electronic data integrity systems.

By working hand-on with these systems and equipment, he has written rationales for risk assessments of alarm lists and parameter lists and combined these lists with automatic collection of audit trail and alarm logs. He has tested the systems from line actions, to storing data on servers and finally by verifying whether correct data is available in batch journals for product releases.

As a consultant, Frederik has a logical mindset which helps him with problem solving in an efficient and high quality way.

“I like to do things the right way as GMP requires and to find solutions that fit the client and their needs best. I very much like improvements and eliminating errors. By doing this, we deliver a higher level of safety for the patient. That is nice to think about."