FDA CDER/ORA Compliance Policy Guide Sec. 425.400 “Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)” revised 4-Sept-87. Indicates that input/output checks are required by 21 CFR 211.68 even if the computer system is validated and explains the rationale for this. It allows for the rigor of the checks to vary depending on the complexity of the system, its built in controls.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation, monitoring