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The Ulimate Server Qualification Template

Graham O'Keeffe - Premier Validation

So you’ve just finished validating your software application and your ready to go live, then some guy in the validation department asks (or worse a FDA Auditor) “Have you qualified the server the application resides on?” After all the work that’s involved in validating the application you now have to worry about the server.

So who is responsibility for qualifying the server? In my view what usually happens is that the validation department generates the validation protocol, with input from the IT department.

Once approved by the stakeholders the approved protocol is then handed over to the IT department for execution.

Fail to prepare, prepare to fail – Top Tips for Protocol Execution

The AskaboutValidation Team

What should a test protocol contain? What is the typical content of a test protocol? Before any test execution takes place there are a number of checks you must do before entering into the world of test execution. “Fail to prepare, prepare to fail” no truer words can be spoken in relation to protocol execution. How many times have you seen executed protocols with deviation after deviation or observation after observation?

Can this be prevented or do you have to have executed protocols with mark ups everywhere on the document. Its one thing to have a clean protocol with no deviations or mark ups (rarely happens and would raise suspicion with the FDA) but its quite the opposite to have a protocol littered with mark ups everywhere to the point where someone has to ask the question "Has this been given a dry run".

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