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Message Icon Topic: Regulatory impact on test management tools

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tanushree
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Quote tanushree Replybullet Topic: Regulatory impact on test management tools
    Posted: 17Oct2007 at 3:53am
Regulatory impact on test management tools

There are many regulatory requirements designed to ensure that organisations develop and implement systems that work as intended, meet stated requirements and are fit for purpose. While test management tools are specifically designed to assist with implementation of new systems, some regulations go a step further and ask for complete control over all validation evidence acquired during the lifecycle of the system.
This includes:
•Use of electronic and digital signatures
•control of system access
•securing records from alteration, deletion or data loss
•use of system functions that allow uncontrolled additions, deletions or changes to electronic validation records.

When using test management tools to create, maintain and store electronic records that form part of a validated system configuration, Part 11 requirements apply to the tools in the same way as the system being developed and implemented.



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