Overseas Firms Struggle With Software Protocols During U.S. FDA Inspections – Bio Korea
This article was originally published in PharmAsia News
Executive Summary
OSONG, South Korea - Many firms outside the U.S. fail to designate a key person to handle the software side of clinical trials and are subsequently hauled up for the lapses via U.S. FDA warning letters over computerized validation systems, an expert on drug company information systems said during the annual Bio Korea conference in Osong, South Korea Oct. 10