Verification & Validation (V&V) Traceability - What are the benefits and limitations?

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
:topic: You can also format what you want in ASCII and then use the 'code' tag to keep spacing, I believe.
Code:
                 MMM           \|/            www            __^__ 

                (o o)          @ @           (O-O)          /(o o)\
 
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W

wrodnigg

#12
:thanks: for the hints :read:

I added arrows indicating the testing.

This is the basic V-model. In more complex projects there should be als a Design Qualification (DQ) which is carried out over the whole specification branch. During DQ one assures that UR, FS and DS are "corresponding" documents. This is not more or less than assuring "traceability" throughout the specification branch.

Next time I will root up my archives and post a diagram for easier understanding and better clearance.

I have written a short sample traceability-matrix:

Requirement ID# and Description should be clear. It is important to document the source of requirements (meetings, standards, laws...). GxP-Impact and Part-11-impact are essential in regulated environments. After the functional specs, the main risk assessment is done and documented. design spec# and System module are needed in custom-made projects and are omitted when dealing with COTS-Systems. Test Ref # should be clear. If there were any issues during the project, they have to be logged and the corrective ot preventive action documented.

Such a document is the heart of a validation project. It costs additional time, but it is worth the effort.
 

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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#13
Folks,

I am a bit confused.....and would like to understand what this thread is actually discussing. Any education is appreciated.

I am a Metrologist (calibration geek) and we have our own world........and in our world, verification and validation are significantly different than traceability.

There is a little interaction between them, but they are different. Verification for us means it works, validation means it is fit for use.....and satifies ISO/IEC 17025 of course.... :D

Traceability has to do with tracing measurements back through national or international standards to SI units.

Now, having said all that, the obvious meaning here appears to be different.

Hence my confusion.

Hershal
 
M

Magdalena

#14
Validation report of system AXAPTA release 2,5 ???

Hello Everybody!!! :bigwave:

I am simply new in this forum and I can see that it is vonderful place to share with knowledge, experience and skills.

I can see that some of You have realy deep knowledge in validation process (aspecially You wrodnigg :) ) So I have to say that I have big problem and I would like to get some help from someone really kind.
My problem is that I need to find any organization which has a validation report of MBS-AXAPTA system (product of Microsoft Corporation). I am aware of that this kind of document costs some money, but inspite of I can't find the Company which will be able to sell it to other one.
Is someone there who can help me or just give me information about companies which are ready to sell this kind of document?

Please help me!
 

Govind

Super Moderator
Staff member
Super Moderator
#15
Hershal,
This traceability matrix is used heavily in Software (SW) development. It is good practice for implementing Software Standards like ISO9000-3, ISO/IEC 12207 LCM.

The idea is to ensure that customer requirements are traceable from Requirement definition to Highlevel design, Detailed design, Coding, Testing, Verification, Validation through effective configuration management. Any changes that are made to the process during the life cycle can be traced to Customer requirement to identify the impacts.

This ensures that No customer requirements are missed while designing and testing the SW product.

My Opinion:Effective deployment can be achieved through Quality Function Deployment(QFD) where we obtain the voice of Customers, input through Planning, design, process and production houses of Quality.In the SW context, upto process house is more relevant.

Regards,
Govind.
 

Al Rosen

Staff member
Super Moderator
#16
Magdalena said:
Hello Everybody!!! :bigwave:

I am simply new in this forum and I can see that it is vonderful place to share with knowledge, experience and skills.

I can see that some of You have realy deep knowledge in validation process (aspecially You wrodnigg :) ) So I have to say that I have big problem and I would like to get some help from someone really kind.
My problem is that I need to find any organization which has a validation report of MBS-AXAPTA system (product of Microsoft Corporation). I am aware of that this kind of document costs some money, but inspite of I can't find the Company which will be able to sell it to other one.
Is someone there who can help me or just give me information about companies which are ready to sell this kind of document?

Please help me!
Magdalena:

Welcome to the Cove.

I did a search and came across this site. It may be hellpful in that it reeferences a white paper for FDA compliance. I didn't have time to review it, but I thought I would pass it along.

http://www.microsoft.com/BusinessSolutions/Industry/LifeSciences/FDA.mspx
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
FDA compliance is at the heart of the Life Science Industries

Thanks for the link, Al!

Quick Quote from the paper:

FDA compliance is at the heart of the Life Science Industries. The executive’s dilemma is balancing compliance with the demands of the market and stockholders. This challenge is fundamental to the success of the Life Science enterprise. Much confusion exists in the mid-market about those very regulatory issues. Key concerns include:

• How does the enterprise decide what compliance means to it?
• What strategy is right to balance risk with the compliance effort?
• What is the right balance between human and automated efforts?
• Who is responsible for compliance?
• Where does automation fit into the effort?
• What is IT’s role in compliance?
• How do we select our automation partner?

This document is intended as a guide to addressing these questions for the mid-market Life Science executive.

Direct Download Link: http://download.microsoft.com/downl...5-4853-b362-715690738b6d/fda_lifesciences.pdf
 
M

Magdalena

#18
Hello Al :)

Thank You very much for this link. :thanx:
I hope it will be helpful for the project which I attent :)

Sincerely,

Magda
 

Al Rosen

Staff member
Super Moderator
#19
Magdalena said:
Hello Al :)

Thank You very much for this link. :thanx:
I hope it will be helpful for the project which I attent :)

Sincerely,

Magda
Magda:

I don't think that you may use someone elses vaklidation of the software. I believe it will be up to you perform the validation of the software in your system and your application of it. Besides, if you purchased it from IBM or some other reputable vendor, they would likely be willing to support your effort to validate it.
 
S

SteveR

#20
Traceability Benefits...

Donald Duck,

First let me clarify what is meant by traceability - in the context of medical devices, it usually refers to requirements traceability. This means providing documentation of where in the device (hardware, software, etc.) each requirement identified in the Design Input document is implemented. From a software perspective, the requirements trace usually is represented as a table that has the following columns left to right:

Requirement
Safety Critical?
Design Spec
Implementation
Validation Tests

By creating this table, it is then possible to assess verification and validation activities that may be required as the requirements change - which we all know they will.

If you would like to learn more about V&V and requirements tracing, I would recommend you read my book:

Software Verification and Validation for Practitioners and Managers, Artech House, 2001. Its available at amazon.com and many other sources.

I would also recommend that you have a look at my web site for some training that may be of help to you and your organization:

http://www.swqual.com

Regards,

-Steve Rakitin-
 
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