21 CFR Part 11 compliant Instruments: Breaking down dangerous misconceptions
QP, QC and laboratory managers are liable for lost data. Unknown to many lab professionals, a standalone system with electronic records is problematic. These systems can risk a laboratory being issued an FDA warning letter and incurring extremely high costs.Several companies from the pharmaceutical industry have recently asked for 21 CFR Part 11 certification for instruments that are not connected to a PC, so just using the instruments’ firmware. Some instruments in the market are apparently off...
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