CSV FDA Warning Letters : ERP and Calibration

Date: 07 May 2009
Link: FDA Warning Letter (New Window)

Observation4. Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing and holding of a drug product. [21 CFR 211.68]

Part A
A. The Enterprise Resource Planning