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Services > Qualification & Validation

Filamatic - Qualification & Validation - 2015

TECHNICAL EXPERTISE, AND DETAILED REVIEW

 
Filamatic's Good Manufacturing Practice (GMP) aligned Quality Policy is used internally to ensure that we produce a top quality product that meets the expected result.
 
Filamatic can offer a complete, reproducible and documented proof that the machine has been manufactured according to the purchase order, the proposal, design documents, and the specification.
 
Machine validation can include:
 
Installation Qualification (IQ) is the testing and documentation of selected criteria for correct machine construction. The following items can be included in the test schedule:
 
  • Fulfillment of the customer order specifications
  • Installation and identification of mechanical components
  • Installation and identification of electrical components
  • Installation and identification of the machine control (PLC)
  • PID/RI diagrams
  • Technical data sheets for the components
  • Flowchart of the machine program
Operation Qualification (OQ) is the testing and documentation of selected criteria for correct machine construction. The following items can be included in the test schedule:
 
  • Operational inspection of the machine control (PLC inputs and outputs)
  • Operational inspection of the machine program
  • Operational inspection of the operating panel
Typically, Filamatic structures the IQ/OQ documentation. If the customer wants Filamatic to execute the OQ, then please ask us to quote separately. Filamatic employs several contractors to execute OQ's to maintain impartiality.
 
F.A.T. PROTOCOLS:
 
Filamatic offers as a service to our customers the creation of FAT processes. Having served multiple industries, Filamatic is well versed in creating Pre-FAT and FAT documents for review and approval by you, our customer.
 
Program features and benefits:
 
  • Speed up creation of specifications
  • Decrease time to create protocols
  • Significantly reduce post FAT list of changes