Validation

Validation

Sovrin are committed to meeting customer specifications in relation to design, manufacture and qualification of all processes, facilities and equipment. Design, installation, operational and performance qualification ensure complete and seamless validation.

  • Full validation of mould tools, processes and equipment
  • Creation of Validation Master Plans covering all aspects of:
    • Design Qualification 
      Component DFM, Mould tool design, URS, Risk Assessment, FAT
    • Installation Qualification 
      R & R, MSA, SAT, Equipment Environment Facility
    • Operational Qualification 
      Process optimisation, Process capability analysis, Functional & dimensional assessment
    • Performance Qualification 
      In-process testing, Product training, Batch traceability, Production control
    • Final Summary Report 
      IQ/OQ/PQ Checklists, FAT & SAT Reports, FOIRs/ISIRs, MSA/R & R Studies, Capability Studies, Interchangeability Studies