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Part 11 “Add-on” Coverage to FDA Surveillance Inspections Shedding Light on Industry Gaps

FDA is getting a better handle on where industry is having problems applying Part 11 as the results from its “add-on” coverage of computer systems during routine surveillance inspections begin to emerge....

CDER Will Focus on Part 11 Compliance in Upcoming Inspections

FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations. The inspection findings will be used to assess whether or not its related regulations and guidance need to be adjusted....

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