Validation report of AXAPTA according to GAMP4

[Magdalena]

Hello every body!

I am now in some awkward situation. I am involved to the project of MBS-AXAPTA system validation.
We have validated all programms and customizations made in this system but we still don't have the validation report of core (standard) of the MBS-AXAPTA system to improve that everything is validated.
Have You heard about company which is ready to share with this kind of document which is based on GAMP4 and which proves that AXAPTA system is in validated state. I am aware of that this kind of document may cost some money but I can't find any company which is ready to share with it.

Please help me

Any suggestions or informations will be realy useful.


Sincerely,

Magda[/COLOR][/COLOR]

[wrodnigg]

Hello Magdalena,

just copying (buying) a validation report does not work (for any company).

You cannot buy validation, or buy a pile of paper to put it next to a computer system and declare it as "validated".

Validation is a sub-process of life cycle management.

The validadion report should be a summary of your validation activities, so it is more or less unique for each system.

So you just have to gather a high-level summary of your project in a report.

[Magdalena]

Thank You Wrodnigg for Your answer,

I know that validation is the whole process and we have done validation of this system according to model V described in GAMP4. That's mean we have done URS's, RIA's, Design Specifications, Technical Specifications and all required tests.
Now we are preparing the Validation Report of this whole process.
But our TSP's describe only programms and customizations which were made additionaly to the standard system, so the thrue is that we have tested only things which were additional configuration and in this case we can't say that the standard system (without configuration and programming) is validated.
So we are looking for one of two things:
1. Audit report of AXAPTA from the other pharmaceutical company - to prove that business processes work correctly with AXAPTA.
2. or even Quality audit report of Microsoft Corporation who is the producer and distributor of MBS-AXAPTA.
But I know that this second case is rather unattainable or even impossible.
So I have start my search from Audit report of AXAPTA in from other company.

Do You agree with me or still have different opinion in this topic?

Sincerely,

Magda

[wrodnigg]

You could follow a risk-based approach on basis of the whole specification documents (also specs of the basis-system).

You are dealing with a Cat 4 system, and yes - I would really like to do a supplier audit at Microsoft

You could break down the finctionality of the basis system into several classes and define critical functions which you test, and uncritical ones which you don't.

I know a Navision solution provider and I could ask, if they can sell you a validation whitepaper-package for Axapta...

[Magdalena]

I would be very glad if You will ask him and give me the answer soon

Regards,

M.