FDA CDER/ORA CPG 7132a.11 Software as Records

FDA CDER/ORA Compliance Policy Guide 7132a.11Section 425.100 revised 4-Sept-87 “Computerized Drug Processing; CGMP Applicability To Hardware and Software” . Establishes approach to applying Drug GMP to software and specifies software will be treated as records.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation

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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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