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Other Regulatory Compliance Services

  • Due diligence assessments
  • GxP IT, Information Master Planning, and Security Roadmap Development
  • Person-in-Plant
  • Organizational Change Management
  • Business Process Analysis
  • Computerized System Evaluation and Selection
  • Qualified Person Support
  • Computerized System Assurance Support

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.