Our field service teams provide validation and documentation services to support IQOQ processes designed to ensure that your Instron testing equipment performs to its intended purposes and produces valid results per 21 CFR 820.72 and ISO 13845. At the conclusion of our services we provide a Completion Certificate for Installation and Operational Qualification that will be signed by the Instron Field Service Engineer who performed the validations.
IQOQ Support Services
Installation Qualification (IQ)
An installation qualification process is designed to establish that the system has been installed correctly. It will consider and document:
- Installation conditions
- Operation of safety features
- Provided system manuals and documentation
- Environmental conditions
Appropriate services and utilities manuals should be used to provide system requirements when applicable. Pre-installation and installation documentation will ensure that installation was performed correctly.
Operational Qualification (OQ)
An operational qualification process is designed to verify the proper operation of the testing system and its ability to produce valid results. A typical validation plan includes the following:
- Transducer verification (per Instron's standard verification/calibration procedures, certificates are provided for each transducer).
- Speed and displacement verification (per Instron's procedures; certificates are provided for both verifications).
- Software functionality check
Performance Qualification (PQ)
Performance qualification is complex and requires identification of the specific types of tests and calculations to be performed by the system in your test environment. Instron's support of PQ processes is typically limited to the validation of results reported by Instron software, but consultation services can be provided to assist customers with their PQ processes.