Topic: Using TestDirector to Support Validation Processes

Message

   Using TestDirector to Support Validation Processes

Adherence to appropriate methodologies and controls is especially vital in regulated environments.
TestDirector promotes best practice for computer systems development and implementation.

Control of the Test Process
Reliance can only be placed on systems that are developed, implemented and maintained in a controlled environment. 

There are many enhancements to TestDirector that achieve this control:
System Access
TestDirector’s
login process has been enhanced to meet Part 11 requirements fully.
User passwords can no longer be shorter than 7 characters and must
include an alphanumeric capital and a numeric character. Password
ageing has been implemented, invasive login attempts are now logged and
the appropriate warnings posted to administrators.

Workflow
TestDirector
has a ‘User Permissions’ facility configurable according to user
preferences. This allows specified duties to be allocated to particular
user groups if required. Access to change some system objects can be
controlled by ownership. New features in TestDirector cause some
processes to be conducted in a specific way. For example, once a test
case version has been signed it is no longer possible to refine that
version any further. Test runs can only be conducted only against
approved test cases. Electronic/digital signatures are hard coded such
that they are enabled only at certain points in the test process.

Electronic Signature Application
An
electronic signature facility is built in to TestDirector and
facilitates creation of an electronic equivalent of the user’s
hand-written signature. The facility is enabled only at certain stages
in the test processes. The signature record is linked to the record
being signed and on application, the signed record becomes locked
permanently. A verification function is provided to allow ad-hoc checks
that an electronic signature or its associated record have not been
changed or corrupted in any way.

The benefits of the integrated electronic signature facility are significant:

•Test documentation does not have to be printed out and signed with hand-written signatures and a hybrid system is avoided.
•Logistical problems eliminated as signatures can be applied using a web browser from any location worldwide.
•Test records cannot be altered or falsified without detection as with paper records
•Illegible handwriting eliminated
•Reduced paper costs
•Reduced resource costs due to more efficient processes

Digital Signature Interface
TestDirector
retains the interface to external PKI applications in case users wish
to have digital signature capability. This allows organisations with an
existing digital signature PKI infrastructure to utilise existing
resources. This design has been fully proven using the Entrust PKI
functionality. A digital signature is applied in the same way as an
electronic signature. 

Field and Record Locking
The
core TestDirector product is very flexible in order to meet demands
across industries. A change to a test document can be made from one of
many different views of the test within the user interface. This does
not suit a more stringent validation environment where change is only
allowed via use of controlled procedure such as “change control”. To
that end this open design has been controlled such that changes to test
items can only be made via a single route in the user interface. Fields
are locked from all views except the view where the change would
normally be administered.

To meet the electronic and digital
signature requirements the record locking mechanism is enhanced such
that once the process for signing an electronic record is initiated,
all external ‘write access’ to the record being signed is disabled
regardless of whether a third party was accessing the record.

Duplicate Records
To
avoid conflicts TestDirector does not allow records with identical
names to exist within the same hierarchical structure. Test cases must
have unique names regardless of the fact that their system ids are
different. The same applies to test runs where the Run ID (typically an
iteration number 001, 002 etc) must be unique.

Electronic Record Deletion
Deletion of electronic records in TestDirector is not permitted

Author	Message
tanushree Senior Member Joined: 04Apr2007 Online Status: Offline Posts: 2160	Topic: Using TestDirector to Support Validation Processes Posted: 17Oct2007 at 4:15am
	Using TestDirector to Support Validation Processes Adherence to appropriate methodologies and controls is especially vital in regulated environments. TestDirector promotes best practice for computer systems development and implementation. Control of the Test Process Reliance can only be placed on systems that are developed, implemented and maintained in a controlled environment. There are many enhancements to TestDirector that achieve this control: System Access TestDirector’s login process has been enhanced to meet Part 11 requirements fully. User passwords can no longer be shorter than 7 characters and must include an alphanumeric capital and a numeric character. Password ageing has been implemented, invasive login attempts are now logged and the appropriate warnings posted to administrators. Workflow TestDirector has a ‘User Permissions’ facility configurable according to user preferences. This allows specified duties to be allocated to particular user groups if required. Access to change some system objects can be controlled by ownership. New features in TestDirector cause some processes to be conducted in a specific way. For example, once a test case version has been signed it is no longer possible to refine that version any further. Test runs can only be conducted only against approved test cases. Electronic/digital signatures are hard coded such that they are enabled only at certain points in the test process. Electronic Signature Application An electronic signature facility is built in to TestDirector and facilitates creation of an electronic equivalent of the user’s hand-written signature. The facility is enabled only at certain stages in the test processes. The signature record is linked to the record being signed and on application, the signed record becomes locked permanently. A verification function is provided to allow ad-hoc checks that an electronic signature or its associated record have not been changed or corrupted in any way. The benefits of the integrated electronic signature facility are significant: •Test documentation does not have to be printed out and signed with hand-written signatures and a hybrid system is avoided. •Logistical problems eliminated as signatures can be applied using a web browser from any location worldwide. •Test records cannot be altered or falsified without detection as with paper records •Illegible handwriting eliminated •Reduced paper costs •Reduced resource costs due to more efficient processes Digital Signature Interface TestDirector retains the interface to external PKI applications in case users wish to have digital signature capability. This allows organisations with an existing digital signature PKI infrastructure to utilise existing resources. This design has been fully proven using the Entrust PKI functionality. A digital signature is applied in the same way as an electronic signature. Field and Record Locking The core TestDirector product is very flexible in order to meet demands across industries. A change to a test document can be made from one of many different views of the test within the user interface. This does not suit a more stringent validation environment where change is only allowed via use of controlled procedure such as “change control”. To that end this open design has been controlled such that changes to test items can only be made via a single route in the user interface. Fields are locked from all views except the view where the change would normally be administered. To meet the electronic and digital signature requirements the record locking mechanism is enhanced such that once the process for signing an electronic record is initiated, all external ‘write access’ to the record being signed is disabled regardless of whether a third party was accessing the record. Duplicate Records To avoid conflicts TestDirector does not allow records with identical names to exist within the same hierarchical structure. Test cases must have unique names regardless of the fact that their system ids are different. The same applies to test runs where the Run ID (typically an iteration number 001, 002 etc) must be unique. Electronic Record Deletion Deletion of electronic records in TestDirector is not permitted Post Resume: Click here to Upload your Resume & Apply for Jobs

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Deepti Taneja Newbie Joined: 30Jul2008 Online Status: Offline Posts: 1	Posted: 30Jul2008 at 3:14am
	hi ur knowledge is gud for TD. Can u pls tell me how i can start with TD,,,,i mean regarding Set Up of TD....So that i can use it
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