Plant & Operation Validation

Whether you are installing a new state-of-the-art automated packaging line or calibrating a balance, you must have complete control – and be able to prove it. We can help you.

Our clients' success – and credibility – depends on their manufacturing facilities operating consistently and reliably year after year. We help our clients achieve the highest levels of efficient product throughput possible, for the highest level of profitability, while meeting industry regulations.

Areas of Expertise

• Life Cycle and Opportunity Cost Analysis
• Global Validation Strategy and Validation Master Plan
• Project Management
• Gap Analysis and Risk Mitigation
• Process Improvement
• On-site Staffing

Business Operation

• Author Standard Operating Procedures
• Capital Planning
• Controls & Automation (GAMP compliant)
• Facility Construction and Relocation
• Equipment Specification, Installation and Validation
  • Design Specification (DS)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
• Performance Qualification (PQ)
• Supply Chain and Manufacturing Optimization
• Technology and Manufacturing Transfer
• Validation Operations
  • Cleaning Validation
  • Method Validation
  • Process Validation
  • Metrology
  • Temperature Distribution and/or Penetration Studies
  • Test Script Authoring and Reviews