I/O Checks FDA CDER/ORA CPG 7132a.07 Monitoring

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

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.