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  GAMP Requirements

1. Maintenance of the actual validated situation

All changes are Documented

Compliance of all standardized
processes

2. Quality assurance in development process

Software-
developmentcycle (PDCA) Validationstrategy: processes, software


3. Target: Data integrity

Traceability from
the Specification

Planning and Documentation
of all project steps

   
 
   
 

 

 

 

GAMP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Weist EDV offers Software Solution Validation for the medical and pharmaceutical industries. The GAMP Guideline act as a benchmark to guarantee the computer systems validation compliancy with the industrial norm.

Throughout the project duration, from the start till completion, we ensure that the approved validation and specification was complied with

With an adapted softwre development process model, based on the V-Model, we aim to develop first-rated solutions.



 
   


Process for software development

 
   


The process model based on the V-Model for software development, is chronological built. The active individual is found on the left hand and is assigned the development steps in the middle column, while the column on the right show the relevant documentation.

In the first phase the client acquires a User Reserach Specification (URS). Weist EDV conducts during the following development steps the user research, development, management and testings.

 
   


The GAMP Guidelines is an attempt to keep the complete software development cost at a minimum, while at the same time maintaining transparency during the software development, and ensuring that the quality is maintained. It is also to ensure that upgrading and development of software solutions are standardized and transparent.

We are able to offer you this wide range amenities through our years of experince with the pharmaceutical industry.

 
 
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  What is validation?
 

 

The validation proof of the computer-based system is provided through documentation. This ensures that the computer system produced has met with the high standards set out and that the specifications provided were adhered to.

 

       
  Information
 

 

You are welcome to contact us for more informaiton

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