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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

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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.