FDA CDER/ORA Compliance Policy Guide Sec. 425.500 “Computerized Drug Processing; Identification of “Persons” on Batch Production and ControlRecords (CPG 7132a.08)” revised 4-Sept-87. Allows that the identification requirements of 21 CFR 211.188(b)(11) could be met with a computer system instead of a person and indicates specific requirements for the computer system including validation.

SoftwareCPR keywords: software, drugs, pharmaceuticals