Risk Based Computer System Validation – A New Approach

I have been dealing with Computer System Validation for over 7 years now. People who deal with this will say it is a nightmare in terms of the amount of documentation it generates and also the practicality of the whole process. Add buggy or faulty systems delivered by software development teams, the problem will be compunded and will drive everybody in the project crazy.

One development over the past few years that has tried to reduce the burden of validation of computer systems and the corresponding documentation is “Risk Based Validation”. The basic premise of this approach is to identify the risk of each requirement and only test the requirements that pose high risk to the critical nature of safety of patients, consistency or data etc. This sounds like a very common sensical approach. However, the adoption has been really slow for various reasons. Here’s an article by Mr. Richard Van Culin on Applied Clinical Trials magazine that highlights the challenges of such an approach and recommends a more practical two phased approach. Good read for Validation & Verification professionals as well as IT teams dealing with software development with GxP implications.

New Approach to System Validation – Applied Clinical Trials.


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About Venu Mallarapu

I am currently working as Associate Director at Cognizant Technology Services in their Life Sciences division. I have over 15 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for about 9 years. I have worked with small to large pharma customers to address various business requirements in R&D, Sales and Marketing areas. IT Service Management is one of my other passions. I blog and write about technology frequently and have also presented at various conferences and workshops on wide variety of topics in technology.

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