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How to validate software development tools used for GXP and MedDev?

(You can even use this reference to validate Jira itself)  

When does a software tool require validation?

if software tools are used for any process which affects your product or quality systems, then that process has to be validated. A key distinction is that it is not the software tool as a stand alone product which needs to be validated, but rather your actual use of the product within your specific intended use which needs to be validated.

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Planning for Validation

Planning your project and planning your validation are very closely intertwined, and when your project process is mature, then these will converge to be  the same thing.

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Process mapping

Before embarking on the project, it is important to first agree on the eventual business process. This is why a process mapping exercise is critical; it provides you with the opportunity to gather input from stake holders and process participants alike, and align everyone around a common goal.

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Contributors

Join us on the 27.11.2018 in Stuttgart, Germany

How to validate software development tools used for GXP and MedDev?