Systematic and Repeatable Processes

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New Approaches to QMS

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Company Data Sheet

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Pillars of Quality Management System resized 600
 8 PILLARS OF AN EFFECTIVE QUALITY SYSTEM    
                              
QUALITY
  • Design Control and Design Validation                                       
  • CAPA System Design & Implementation
  • Investigation Facilitation
  • FDA-483, Warning Letter and Consent Decree Resolution
  • Quality System Development, Implementation and Improvement

COMPLIANCE

  • Regulatory Enforcement Response/Resolution 
  • Inspection Preparation and Readiness
  • Regulatory Inspection Management and Support
  • Auditing
  • Quality System Compliance Gap Analysis
  • Quality System Development and Deployment
  • Risk Analysis

VALIDATION