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

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

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