Quality Documentation

Good Automated Manufacturing Practice (GAMP) methodology

SYSTEMATIX provides a comprehensive approach to quality documentation on every automation system we design and build. We understand the importance of following industry standard documentation practices such as Good Automated Manufacturing Practice (GAMP) methodology.

Quality Documentation

 

Functional Requirements Specification

We provide a detailed Functional Requirements Specification (FRS) at the inception of every project. The FRS outlines system functions, capabilities, output, appearance, and interaction with user operators. It is used as a guide for the design of the system according to customer specifications.  

SYSTEMATIX Design Specification

A detailed SYSTEMATIX Design Specification (SDS) is also prepared for every project. The SDS outlines industry standards – including best design practices, customer specifications, and our standard mechanical and electrical design components.  SYSTEMATIX application engineers review client preferences and specific standards and integrate them into the SDS where appropriate.  

Factory Acceptance Test

SYSTEMATIX Health Science customers can expect a Factory Acceptance Test (FAT) document to be presented prior to shipment that verifies all aspects of machine performance listed in the SDS and FRS.

Site Acceptance Test

As a final measure of quality, a Site Acceptance Test (SAT) document accompanies every SYSTEMATIX machine upon delivery to the customer’s facility to reconfirm all aspects of performance tested during the FAT. 

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