IVWRS Audits

Maintaining control of study randomization and IMP supply chain requires well constructed and validated systems that enable sponsors to effectively manage limited supplies of IMP and ensure that study subjects are properly accounted for. Our Interactive Voice & Web Recognition Software audits investigate not only GCP compliance but also Good Computer Validation Practices. Our IVWRS auditors are well versed in Part 11 compliance, Software Development Life-Cycle investigations and how these systems are used in Clinical Research.

Among the areas investigated during IVWRS audits are:

• Validation status of the computer systems (hardware, software)
• Is the validation documented? And does this include:
  • Functional Requirements Specifications?
  • User Requirements?
  • Installation Qualification (IQ)?
  • Operation Qualification (OQ)?
  • Production Qualification (PQ)?
• Are the validation documents signed off properly?
• Are test failure work arounds explained adequately?
• Enterprise integration testing and evaluation

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