FDA CDER/ORA CPG 7132a.08 Computerized ID

FDA CDER/ORA Compliance Policy Guide Sec. 425.500 “Computerized Drug Processing; Identification of “Persons” on Batch Production and ControlRecords (CPG 7132a.08)” revised 4-Sept-87. Allows that the identification requirements of 21 CFR 211.188(b)(11) could be met with a computer system instead of a person and indicates specific requirements for the computer system including validation.

SoftwareCPR keywords: software, drugs, pharmaceuticals

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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