Qualification and Validation
Technical Expertise with 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. In certain industries, FILAMATIC has a target audience where specialized documentation to qualify equipment and to comply with industry guidelines and regulations is required. We 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 listed specification.
Machine validation is based on risk assessment. FILAMATIC offers competent support in qualification and validation. We can offer qualification packages tailored to your requirements.
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)
- Document history
- Discrepancy report
- P&ID review
- 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
- Independent format test cases
FILAMATIC can create a structured IQ/OQ documentation. Optionally, FILAMATIC can assist in the execution of the OQ. Please ask us to quote separately. FILAMATIC employs several contractors to execute OQ’s to maintain impartiality.
Factory Acceptance Testing (FAT) Protocols
FILAMATIC offers as a service to our customers the creation of a FAT protocol. 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
Site Acceptance Testing (SAT) Protocols
FILAMATIC offers as a service to our customers the execution of SAT processes on-site at your location.
For more information on Qualification & Validation options for your specific applications, please email firstname.lastname@example.org or call 866.258.1914.