Validation Management

Life-cycle Validation

• Life-cycle Validation Strategy:
  • VMP. Risk Assessment. Qualification Matrix / Strategy.
  • Life-cycle Validation Strategy
• Process Validation:
  • Manufacturing Equipment Qualification
  • Process Design: CPPs – CQAs – PPQ – CPV
• Analytical Methods Validation:
  • Lab Equipment Qualification
  • Cleaning Validation
  • Design – Sampling – Limits definition
  • Facilities / Utilities Qualitification
  • HVAC – PW – WFI – CIP/SIP
  • IT Systems Validation