Regulatory Compliance / Commissioning / Validation

  • Cleaning Validation
  • Commissioning, Start-up, Factory Acceptance Tests (FAT)
  • Compliance Services
  • Computerized Systems Validation
  • Document Control
  • Engineering Specifications
  • Environmental Monitoring Programs
  • Facilities, Utilities, Manufacturing/Packaging Equipment Qualification
  • FDA Regulations Assessment
  • Functional Requirements Specifications
  • Installation, Operational, Performance Qualification Protocols and Laboratory Systems
  • Process Validation, Process Investigations
  • Quality Assurance/Validation Master Plans Reports
  • Steam In Place (SIP) Validation
  • SOPs, Guidelines, Audits
  • Summary Reports
  • Testing Execution