Ask the Consultant: Computer System Validation (CSV) Advice

"What tips for you have for performing a CSV?"

Computer System Validation is an essential and complicated task for regulated computer systems.  It can be challenging, which is why learning from each validation performed can help make all future validations easier, with fewer deviations.  This learned experience can only be obtained from executing a validation and not just learning how to perform one.

Each validation provides experience and knowledge by doing rather than reading on how to perform tasks. Within CSols our team has performed many Computer System Validations on a variety of systems which has allowed the validation experts to learn various lessons and strengthen their skills. We share these lessons with one another and now would like to pass some along to you. So we took some time to look internally, evaluate our past projects, and capture a list of tips that we feel could help you perform a better CSV.    

project plan help you avoid them assess risks risk based Guidance Scope creep

What have you learned from performing a computer system validation?  Have you seen any of the issues above?

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