Solutions and technical support for the FDA regulated industry

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SERVICES

Validation

Validation is the cornerstone of ensuring compliance and quality in the bio pharma industry.

Our validation services encompass a comprehensive approach to verifying and documenting processes, systems, and equipment to meet regulatory requirements. From equipment qualification to process validation, we ensure that your operations meet the highest standards of quality and reliability.

  • Manufacturing and Packaging Process Validation
  • Process Validation and Investigation
  • New Product Techonology Transfer
  • Cleaning Validation
  • Analytical Methods Validation and Transfer
  • Kneat Paperless Validation Software
  • Steam in Place (Sterilization, Validation, Autoclaves, Clean, Stearn Generation and Distribution)
  • Equipment Thermal Mapping (Kaye Validator, Elab Monitoring Sytems and others)
  • Risk Base C&Q Cleaning and Process Validation
  • Prospective, Retrospective and Concurrent Validation
  • Revalidation
  • Validation Master Plans
  • Process Support
  • Packaging Equipment Validation (Fill, Finins ines, Labelers, Inspection Systems)
  • Facilities, Utilities, Systems and Equipment (FUSE) Validation
  • Validation Maintenance
  • Air Flow Pattern Testing (Smoke Studies)
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