2013 to 2015 Data Integrity Issues related to Computer Systems

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Here is a great resource to gain an understanding of FDA’s perspective on data integrity issues relating to the use of computer systems.  FDA 21CFR Part 11 and the European Union’s focus on data integrity are resulting in an increase in the number of observations during an inspection.

Read more about cases of data integrity issues here. (updated September 2015)

Information compiled by Orlando López, Data Integrity SME.