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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.Building Blocks of Risk Based Software Validation_IQS

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?

Process Mapping

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.

Risk Assessment

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.

IQS Software Validation Process Mapping
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

<< Read Part 1: What is Risk Based Software Validation?
>> Read Part 3:  Risk Assessment in Risk Based Software Validation

Michael Heaps

Michael Heaps was born and raised just outside of Manchester, in the United Kingdom. He started his first job for a computer manufacturing company at 20 years old, after completing a year-long technical college program in Computer Sciences and has been in the Manufacturing and Quality Management Software Industry for over 30 years. In 1998, the company Heaps worked for furthered their expansion and asked him to move to the United States with his family; his wife of 28 years, daughter and son. Heaps started working with IQS, Inc. full-time in 2008 to help provide Project Management Leadership and Customer Account Management. Since then his responsibilities have grown to include: VAR Channel Support and Development, IQS Validation Services and IQS Internal Quality Assurance and Release Management. Between the close-knit working environment and interaction among customers Heaps enjoys what he does for IQS, Inc. On a personal note, Heaps enjoys reading, camping and hiking and is heavily involved in supporting the local community theatre where his wife is the Business Manager. His children are now both grown with one working in the field of law and the other an Actor/Director.

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