Topic: Regulatory impact on test management tools

Message

   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.

Author	Message
tanushree Senior Member Joined: 04Apr2007 Online Status: Offline Posts: 2160	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. Post Resume: Click here to Upload your Resume & Apply for Jobs

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