Who can tell me what is the traceability method for V & V, and what is the benefits of the method and limitations?

some advices?

:bonk:

What is V & V?

What is V & V?I would suppose he is referring to
Verification & Validation
but I haven't a clue how to relate that to "traceability."

How about elaborating on the circumstances surrounding your V&V, Donald Duck? Do you mean "Verification & Validation?"

Fess up Donald,

What is V&V?:bigwave:

Al...

I fess here: V & V is --- I dont know!

Last night I received an email with 5 interesting questions. I post all of them here, not only for the answers, but also wanna initiate some discussion.

Some threads I can provide is: these questions came from a medical equipment manufacturer.

V&V has lent itself to a whole world of interpretation.

Verification, as I understand and preach, is the process(s) necessary to ensure that the product (service) design (components/sub-components) meets or falls into the defined parameters. In aviation maintenance this would include the operational checks of sytem/sub-system components.

Validation, as I understand and also preach, is the process whereby we show through test/operation that the product (service) is capable of meeting all requirements. I equate this to the flight testing of aircraft after maintenance.

Some things cannot be Validated until operated..like the Space Shuttle, or more recently the Mars Rovers.

V&V has lent itself to a whole world of interpretation.

Verification, as I understand and preach, is the process(s) necessary to ensure that the product (service) design (components/sub-components) meets or falls into the defined parameters. In aviation maintenance this would include the operational checks of sytem/sub-system components.

Validation, as I understand and also preach, is the process whereby we show through test/operation that the product (service) is capable of meeting all requirements. I equate this to the flight testing of aircraft after maintenance.

Some things cannot be Validated until operated..like the Space Shuttle, or more recently the Mars Rovers.Pretty much gibes with my understanding of V&V. The question on the table is "tie it to traceability method."

Maybe I need stronger coffee, but unless we are just talking about the record-keeping of those V&V activities, what other method could there be? Am I looking for something more than is [to me] obvious?

Who can tell me what is the traceability method for V & V, and what is the benefits of the method and limitations?

some advices?

:bonk:
Where is the data?
Who did the verification?
When was it done?

Ditto for validation.

Traceability is (IMHO) not a kind of "method", which has benefits or limitations. Traceability is part of a validation process.

Let us assume, we use the V-model for the validation process, then we have the following phases for the validation process:


user requirements <--performance qualification
\ /
functional specs <--operational qualification
\ /
design specs <--installation qualification
\ /
system build

As I mentioned in an other thread (14971 & lifecycle) we are verifying the design specs (DS) in the IQ, the FS in the OQ and the UR in the PQ.

The complexity of testing in the different Q-Phases should be based on the risk of the requirements/specs. We are moving forward from risk assessment to risk management (ISO 14971), therefore risk management should be considered throughout the whole validation procerss.

And now for the traceability thing:

One should develop the FS based on the UR and the DS out of the FS.
And the differen requirements and specifications should be traceable through the whole process:
UR 3.1 is considered in FS 4.1 to 4.4 and therefore we need DS 3.5 to 4.12
Based on the risk of each specification you have certain tests in the IQ, OQ, PQ phases, which validate these specs. And one should be able to trace each requirement/spec to a test case. That is, what is called traceability in V&V.

I use a matrix (Excel sheet), which shows the traces of each requirement (and the risk) through the validation process.

This helps avoiding to forge some requirements and to put on tests, which are not needed.

I hope my explanation is somehow clear. Just ask, if I confused you.

user requirements.............performance qualification
..._____\_______..........___/___________
...functional specs........operational qualification
......_____\___...........___/___________
......design specs........installation qualification
.................\___...____/
..................system build
(ignore the dots, they are used as whitespaces)
:topic: Just for future reference, I hacked the "place holder dots" out of view by changing the text color to white. I got the idea from wrodnigg's comment about "whitespaces."

:topic: You can also format what you want in ASCII and then use the 'code' tag to keep spacing, I believe.
MMM \|/ www __^__

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

: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.

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

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!

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.

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

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/download/3/e/9/3e9f6371-ee45-4853-b362-715690738b6d/fda_lifesciences.pdf

Hello Al :)

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

Sincerely,

Magda

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.

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-