Building Blocks of Risk Based Software Validation
Part 2: Preparing the Foundation
Coming to grips with the task of completing a risk based software validation can be a daunting prospect but the path to a completed validation does not have to be a long, dark and tortuous one. However, preparing the building blocks for your risk based software validation is all-important.
Getting Started With Risk Based Software Validation
The basic premise to keep in mind is that risk based software validation is all about the process. Consider these questions as you get started:
• What is the process that you are following and why?
• Do your user requirements match those processes?
• How do you prove that the software you selected supports those processes?
Going through a Process Mapping exercise is the first step in preparing the foundation of your risk based software validation. Doing this Process Mapping is going to help you know your processes and to then identify where your software ‘touches’ those processes or where your intended use will touch the software. This Process Mapping is going to help you understand what you will need to do next.
The Process Map will use ’swim lanes’ to identify the departments, the processes followed in that department and where the software will impact any of those processes. When you complete the Process Map, you will then have the ‘touch points’ with the software identified and the beginnings of where to focus your attention for the validation.
With the touch points identified, you can now look to the Risk Assessment and analyze each of the touch points to determine what risks each has and what mitigations you either already have in place, or which you need to implement, in order to ensure that the risk associated with each requirement is reduced to an acceptable level. The output of the Risk Assessment will be a detailed FMEA, providing the Functional Requirements document and the identification of the critical elements of your processes. The Functional Requirements is essentially going to be the list of mitigations that you will verify through the Operational Qualification (OQ) that you will perform later.
BONUS: Process Improvements To Save You Time and Money
A major and often unexpected bonus of Process Mapping is that you learn things about your business and the way in which different business areas impact each other. An increased awareness and understanding of why some things happen the way that they do and why the business operates as it does can help identify process improvements that could provide more savings in time and money.
In Part 3, I’ll look at the Risk Assessment phase in a little more detail and review what you need to focus on for the validation.
Read more: LIMS Software Validation