FDA Warning Letters 2008 (computer system validation)
Please find some current US-FDA warning letters on computer system validation:
- http://www.fda.gov/foi/warning_letters/s6847c.htm
- http://www.fda.gov/foi/warning_letters/s6756c.htm
- http://www.fda.gov/foi/warning_letters/s6574c.htm
- http://www.fda.gov/foi/warning_letters/s6704c.htm
Some of them are in the field of medical devices, where inspections increased in the last years and computer system validation is not well established.
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