Regulatory impact on test management tools
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Category: Testing Tools @ OneStopTesting
Forum Name: TestDirector @ OneStopTesting
Forum Discription: TestDirector is a single, Web-based application for all essential aspects of test management — Requirements Management, Test Plan, Test Lab, and Defects Management.
URL: http://forum.onestoptesting.com/forum_posts.asp?TID=2962
Printed Date: 16Dec2024 at 2:14pm
Topic: Regulatory impact on test management tools
Posted By: tanushree
Subject: Regulatory impact on test management tools
Date 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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