gamp4 project

 

24^th January 2006

 

Applied Integration UK Ltd successfully completes GAMP4 project for a major pharmaceutical company. Providing fully documented design and development to ensure the system is compliant.

Standard GAMP4 Project documentation provided:

· Quality Plan

· Project Plan

· Functional Design Specification

· Hardware Specification

· Software Specification

· Implementation

· Change Control

· Factory Acceptance Tests

· Commissioning Plan

· Method Statements

· Site Acceptance Test

 

 

Good automated manufacturing practice (GAMP) provides a strong set of guideline of procedures to follow for the design, implementation and testing of an automated system within the pharmaceutical industry.

Applied Integrations UK’s ISO9001:2000 Quality System is based around the GAMP4 Guidelines.