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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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