Process Validation

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 requirements of FDA and EMA.

Our Capabilities

  • User Requirements Specification (URS)
  • Technical Requirements Specification (TRS)
  • Validation Master Plan
  • Process Mapping
  • Process FMEA
  • Equipment Qualification
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Process Validation Procedure
  • Statistical Sampling Procedure

Key Skills

  • 10+ years experience
  • Approach compliant with FDA and EMA requirements
  • Knowledge transfer
  • Measurement System Analysis (MSA)
  • Test Method Validation (TMV)
  • Design of Experiment (DOE)
  • Six Sigma
  • Integration with your quality management system (QMS)
  • State-of-the-art statistical methodologies compliant with cGMP requirements
  • Data analysis and interpretation
  • Design change consulting
  • Specifications and requirements review and definition
  • Process improvement by experimental design
  • Software Validation

Experience

  • Packaging Validation (ISO 11607)
  • Leak Test Validation
  • US Welding Validation
  • Injection Moulding Validation
  • Design Transfer and Design Control
  • Clean Room Validation (ISO 14644)
  • Sterilization (ISO 11135 - ISO 11137)
  • Support to FAT/SAT
  • Insourcing projects
  • FDA remediation
  • Process Development
  • Support to FAT/SAT and URS definition with suppliers
  • Dip moulding
  • Manual assembly
  • Custom assembly machine validation
  • Lean Manufacturing implementation and training
  • Mock Audit
  • QA procedures
  • RA consulting