FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

FDA CDER/ORA Compliance Policy Guide Sec. 425.200 “Computerized Drug Processing; Vendor Responsibility” (CPG 7132a.12) revised 4-Sept-87. Establishes end user responsbility for validation/suitability of vendor supplied hardware and software used in Drug manufacturing, holding or processing and identifies conditions under which the vendor may also be liable including if they perform hardware/software maintenance on behalf of the users.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation, supplier, COTS, OTSS

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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