LOL and OMG….today everyone knows what these internet slang terms mean and how to use them.
If you are reading this blog you may also be familiar with medical device and life sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of life sciences, we’ll try to debunk the myths around some of the terminology.
So what is meant by IQ, OQ, and PQ? They are terms that fall under the category of validation and verification.
IQ stands for “Installation Qualification”. The IQ records the installation of the software, and ensures that the installation follows the correct steps.
OQ stands for “Operational Qualification”. The OQ tests or qualifies that the solution is working using test data in general. This maps across to the requirements stated in the Functional Specification, and ensures the product or application meets all the predetermined requirements as stated.
PQ stands for “Performance Qualification” which means that the application, under real life conditions, consistently produces products which meet all predetermined requirements. The PQ is the final test before production (potentially the most important test document you will ever run), testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your User Requirements Specification.
On top of the IQ/OQ/PQ, you should ensure that you have other key documents including The Validation Master. This will form the detail and coverage of the documentation that you need.
Last thought for the day is that validation requires documented evidence, if the validation process is not documented then it cannot be proven to have occurred. Put another way, your regulatory body will view your validation process as solely a ‘rumour’.