Microsoft Dynamics NAV 2013 - GAMP 5 Validation

We are a pharmaceutical laboratory in Argentina and we are planning the implementation of Microsoft Navision NAV 2013, we need information on the validation of the same under the standard GAMP 5. I will appreciate information about the protocols primarily to develop, seller required certifications and tests believed to system settings. Greetings and thank you very much. My email:

Somos un laboratorio farmaceutico de Argentina y estamos planificando la implementacion de Microsoft Navision NAV 2013, necesitamos informacion sobre la validacion del mismo bajo la norma GAMP 5. Agradecere fundamentalmente informacion sobre los protocolos a desarrollar, certificaciones requeridas al vendedor, y pruebas consideradas para la configuracion del sistema. Muchas gracias y Saludos. Mi email:

Martin, welcome to DUG!

Never include your email in forum post - so it becomes exposed to bots gathering such info, and will result in heaps of spam in your inbox.

If someone wants to connect you directly, s/he can do so through your profile page - there is an option Send email. (If you entered your email during registering on forum). That method is safe, and your email does not become a public domain.

…now regarding your question:

I haven’t heard / found that this has been done before with Navision (any version).

Don’t know will it be useful for you, but I found only this one: Applying GAMP 5 to Validate an ERP System

and it’s not Navision, they speak about SAP. However, general principles and methods doesn’t change from one ERP system to another