Our installation and services engineering team can provide validation and documentation services to support IQOQ processes designed to ensure that your Instron® testing equipment is suitable for its intended purposes and is capable of producing valid results (per 21 CFR 820.72).
Installation Qualification (IQ) Support Services
An installation qualification process 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
Instron manuals should be used to provide system requirements, when applicable. Pre-installation and installation documentation will ensure that the installation was performed correctly.
Operational Qualification (OQ) Support Services
An operational qualification process designed to verify the proper operation of the testing system and its ability to produce valid results. A validation plan can include system operation validation, transducer(s) verification, functionality check of the software, and validation of calculations. The following outlines the specifics associated with each:
- Transducer Verification - Transducers are verified per Instron’s standard verification/calibration procedures. Data reports and Certificates are provided for each transducer and all standards used are directly traceable to NIST.
- Speed and displacement are not always readily verifiable outside our factories to the factory specifications. The standard verification for these parameters outside our manufacturing facilities is 0.5% of measured value, which is acceptable for the majority of applications. More accurate verifications are possible, but will depend on a number of variables, including available travel, speed, time, and the desired measurements. Higher accuracy verifications are typically not included in our standard verification services, but can be done upon request if possible.
- Standard minimum speed is verified to 1 mm/min (0.040 in/min). Slower speeds are not typically included in our standard verification services, but can be done upon request if possible.
- Software Functionality Check:
- The software functionality check is a “button pushing” test used to ensure that the software is performing as designed.
- This functionality check is tailored to your system and checks the “Test Types” and “Language” (e.g. English, Spanish, etc.) options that you are using.
- A Calculation Test Suite is a document compiled by Instron’s software development team. It consists of Test Methods and Data Files to be replayed on your system and compares results from the software under test with expected results using known data sets as input. The expected results are determined using a variety of independent methods including Mathcad, Excel, hand calculation, and visual inspection. A data sheet for each calculation specified is provided and will be attached to the results produced by the software under test.
We can quote services to validate specific software calculations and will supply a detailed explanation of each algorithm used to calculate a result as part of this service.
Performance Qualification (PQ) Support Services
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. Typically, Instron’s support of PQ processes is limited to the validation of results reported by Instron software; additional requirements are identified within 21 CFR Part 820.
At the conclusion of our validation services we will provide a Completion Certificate for Installation and Operational Qualification that will be signed by the Instron Field Service Engineer(s) who performed the related services and validations. This will certify that the IQOQ services and supporting validations performed by Instron were successfully completed on your system/software.