Our installation and services engineering team can provide validation and documentation services to support IQOQ processes designed to ensure that your Instron® testing equipment and test method(s) are 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 is 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) (force, strain, speed, displacement or temperature) verification, functionality check of the software, and validation of calculations.
Software Functionality Check:
- The software functionality check is used to demonstrate and ensure that the software calculations are performing as designed.
- This functionality check is tailored to your system and checks the “Test Types” and “Language” (e.g. English, Spanish) options 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.
At the conclusion of our validation services we will provide a Completion Certificate for Installation and Operational Qualification. This will certify that the IQOQ services and supporting validations performed by Instron were successfully completed on your system/software.
ComplianceBuilder is an add-on compliance solution that is integrated with specific Instron software. It meets the regulatory guidelines found in FDA 21 CFR part 11 that applies to electronic records created and stored by pharmaceutical, biomaterials, medical device companies and any organisation requiring this level of data security and integrity. ComplianceBuilder allows the user to :
- Create security to predefine access to test methods, data and reports
- Generate electronic records
- Create secure, computer-generated, time- stamped audit trails for all electronic records
- Establish authority checks for e-signatures and record alterations
- Create unique e-signatures with printed name, date and time, and reason for signature
This custom solution allows for a clear upgrade path as the needs of your lab or organisation change.