LIS Validation: What’s In It For Me? (Part 1)
Have you ever wondered just exactly what is a laboratory information systems (LIS) “validation” and if there really is a significant benefit to doing it other than simply to gain regulatory compliance? If so, you’re not alone. Both new LIS professionals and seasoned veterans have asked us many times if LIS validation is more than just a “necessary evil.” I believe the answer is a resounding YES. Through our first blog series, I will take you through the “who, what, where, why and how” of laboratory and blood bank validation. In the end, you will have a deeper understanding of the concept and intent and you‘ll be ready to draw your own conclusions.
Today, let’s start with the first part of “what” – exactly what is software validation? Simply put, it is the entire process of approving new software for use in your laboratory, blood bank or other hospital department and according to the FDA in its “Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility” document published in 2007, it should “assure that the software is suitable for your specific operations and workload, and can accurately and repeatedly meet your needs." The “your” part is critical here. Even though the LIS vendor has tested the software to the best of their ability, no two sites are using that LIS exactly the same way. No one’s test codes and blood products are exactly the same, no one’s workflows and processes are identical - and that is why every institution needs to thoroughly test their LIS – to ensure that is working as expected in your unique environment.
Many people think that "validation testing” and “software validation” are the same thing – they are not. Validation testing is just one of the components of a complete validation as defined by the FDA. A software validation requires a validation procedure, a risk assessment, a validation plan, a validation summary report and defined review/approval steps in addition to the actual validation testing. In the next blog, we’ll break down those validation elements in more detail and the value that each requirement brings to the table.
In the meantime, keep in mind that no one uses their LIS like you do and no one understands your SOPs as well as you, so you’re the only one that can truly validate your system and a well validated system will help ensure your patients’ safety.