Know your processwithout making assumptions

We help you demonstrate your process is consistently delivering quality products.

Validation is a must to gain statistical control on your process, reduce the scraps and meet the market and regulatory requirements.

Our capabilities

  • User requirements specification (URS)
  • Technical requirements specification (TRS)
  • Validation master plan
  • Process mapping
  • Process FMEA
  • Equipment qualification
  • Support to FAT/SAT
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Performance qualification (PQ)
  • Process validation procedure
  • Statistical sampling procedure
  • Measurement system analysis (MSA)
  • Test method validation (TMV)
  • Process Development
  • Design of experiment (DoE)
  • Six sigma
  • Lean Manufacturing
  • Software validation
  • Design transfer and design control
  • Packaging validation (ISO 11607)
  • Support to clean room validation methods (ISO 14644)
  • Support to sterilization validation methods (ISO 11135 - ISO 11137 - ISO 17665)
  • Integration with customer quality management system (QMS)


  • Injection moulding process validation
  • Extrusion process validation
  • Lean manufacturing implementation and training
  • Packaging validation (ISO 11607)
  • Leak test validation
  • Dip moulding validation
  • US welding validation
  • Manual assembly validation
  • UV gluing validation
  • Hot melt and other dispensers validation
  • Ovens and thermal treatments validation
  • Cutting machines validation
  • Custom assembly machine validation
  • Thermoforming and filling machines validation
  • Gage R&R and Attribute Agreement Analysis for Test Method Validation

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