Kneat: Computer System Validation Customer Perspective

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That's pretty impressive. I want to ensure I understand the processes you currently use it for. Could you give a typical example of a computer system validation process? Maybe consider something like a QMS or DeltaV. How does the validation process look for a specific software to make it more tangible?

Let's say, for example, we have a business application that underwent initial system validation when first launched. The documentation for this initial validation includes various documents besides the test scripts typical in IT compliance projects. We have a system validation master plan, IQs, test groups, a user requirement specification, possibly a functional design specification, and more.

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That's pretty impressive. I want to ensure I understand the processes you currently use it for. Could you give a typical example of a computer system validation process? Maybe consider something like a QMS or DeltaV. How does the validation process look for a specific software to make it more tangible?

We do all this documentation, but I'll focus on change control because it's generally shorter. Suppose we launched this application six months ago and now need to implement an upgrade. We must ensure that our clinical affairs group, using the software, will find all the functionality they rely on intact when the vendor upgrades it. We'll initiate a change control project, which involves a change request form, a change control protocol, and IQ documentation.

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That's pretty impressive. I want to ensure I understand the processes you currently use it for. Could you give a typical example of a computer system validation process? Maybe consider something like a QMS or DeltaV. How does the validation process look for a specific software to make it more tangible?

Whether we handle the work internally or the vendor does, we need evidence that they followed their installation steps and verified everything functions correctly. Then we'll conduct performance qualification testing to ensure all previously set user requirements still work. If the vendor adds new functionality we want to leverage, we'll add and test those requirements as well.

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