If your lab is into calibration for the food, beverage and pharma industry, validating calibration software is mandatory.
US law mandates that if the calibration lab is offering services to the food, beverage and pharma industry, the calibration software that is used there should be validated in accordance with Good Manufacturing Practices (GMP), FDA 21 CFR Part 11 and GAMP 5 guidelines.
Let’s take a look at the steps involved in validation of calibration software.
Installation qualification - IQ.
Installation qualification is the first step in the validation process. The purpose of this step is to ensure that the build quality of the lab software and records the installation process of the software. This is to ensure all proper processes are carried out during the installation of the software. Validation in this phase is also based on GMP guidelines, to the extent possible.
Operational qualification - OQ.
In this step mapping of requirements specified in functional specification against the actuals are done. This is to ensure that the pre-conditions and the requirements are adequately met by the software.
For example, it is in this phase of validation that compatibility with FDA 21 CFR Part 11, which ensures compliance with paperless record keeping and electronic documentation guidelines, is tested and validated.
For labs engaging with pharmaceutical companies, GAMP 5 guidelines that ensure that the automated system is appropriate for the use-cases defined by the lab, are validated in this phase.
Performance qualification - PQ.
This is the validation of the data using live data under real conditions. This step ensures the software captures all workflow requirements and is good to go live.
Validation of GAMP 5 guidelines is usually extended to this phase to ensure that the software is appropriately built to cater to the intended usage.
Conclusion.
It is mandatory to re-run the entire validation process every time the software is updated. It is hence important to make sure your digital transformation and software vendors provide the required support each time the validation is run.
Metquay runs a series of checklists to ensure all the above mentioned steps are followed in detail. Also for the purpose of helping the customer re-run the validations, we provide a self service validation guideline. This ensures that no step is missed and the lab continues to remain compliant as per the legal guidelines.
If you would like to know more about digital transformation possibilities of your calibration business, feel free to ping us at consulting@metquay.com. We are here to help you.