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FDA Says Lack of Resources and Staff Hinder Its Foreign Inspections

This article was originally published in PharmAsia News

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Overseas Firms Struggle With Software Protocols During U.S. FDA Inspections – Bio Korea

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

Overseas Firms Struggle With Software Protocols During U.S. FDA Inspections – Bio Korea

Compliance with 21 CFR Part 11 of U.S. regulation covering management procedures for software used in clinical trials is at issue.

Overseas Firms Struggle With Software Protocols During U.S. FDA Inspections – Bio Korea

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

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