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
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software
ISO 14971 Risk Management (typically with heavy emphasis on software aspect)
IEC 81001-5-1 Cybersecurity Lifecycle
ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits
Being Agile Yet Compliant (AAMI TIR 45)
IEC 29119-1 Software and System Testing
US Classification for Software Devices
IEC 62366 Usability Process and Documentation
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