Services
Regulatory ComplianceKnowledge ManagementRisk ManagementWorkforce Enhancement

 Commissioning, Qualification and Validation

Validation

  • Manufacturing Process Validation (PV): Bio, Vaccines, Pharma, Med Devices, Consumer Products
  • Packaging Process Validation (Pkg V)
  • Cleaning Validation (CV)
    • Cleanability Studies
    • Detergents Evaluation
    • Sanitizing Agents Studies
    • Recovery Studies
    • Microbial Load
    • Active Drug Solubilities and Sampling
    • Surfaces Areas and Sampling Points
    • Holding Times (Prior and Post Cleaning Process)
    • Worst Case Studies
    • Bracketing
    • New Approaches to Cleaning Validation
  • Analytical Methods Validation (MV)
  • Analytical Methods Transfer
  • Software Validation and CSV
  • 21 CFR Part 11
  • Network / IT Infrastructure Validation
  • Risk Based C&Q, Cleaning and Process Validation
  • Validation Master Plans
  • Process Support / Monitoring
  • Maintenance of Validated Status: Verification vs. Validation?  We apply QRM most recent approaches 
  • Revalidation


 Commissioning (C) and Qualification (Q)

  • Green Building Commissioning
  • Manufacturing and Packaging Equipment Qualification (IQ,OQ,PQ)
  • Design Qualification (DQ)
  • Maintenance System Qualification
  • Utilities Qualification
  • Facilities Qualification
  • FAT / SAT
  • Risk Assessment
  • Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical
  • Commissioning and Enhanced Commissioning
  • Decommissioning
  • Integrated Validation Approach
  • Suppliers / Materials
  • Personnel
  • Instrumentation


Risk-Based Approach for Qualification

  • Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
  • Leverage testing from Commissioning (Enhanced Commissioning)
  • Eliminate redundant paperwork during qualification
  • Reduce test cases based on risk assessments
  • Interpretation and Application of new standards based on Risk Based Approach
  • Streamline practices and procedures
  • Develop risk management exercises (e.g., FMEA)