FDA CDER/ORA CPG 7132a.08 Computerized ID

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.