VALIDATION

Projects within the food industry and particularly the pharmaceutical industry are characterised by extensive legal requirements, which have to be observed. The methods have to be applied from the establishment and throughout the entire life cycle of the production facilities to ensure the consumer that the products manufactured always live up to accepted specifications.

AN GROUP has the expertise to handle these types of projects � for instance by using GAMP 4 � including the following validation process. Thorough documentation is established to ensure that chosen equipment meets certain specifications and quality characteristics.

AN GROUP offers validation services for existing as well as new computer systems and automation equipment . We assist in determining the validation scope, planning and qualification management based on a categorisation of hardware/software in accordance with GAMP and GxP criticality as well as system assessments in compliance with 21 CFR Part 11.

We carry out all project validation activities, including the preparation of test plans, test schedules, execution of tests, change control and change management as well as related documentation and reporting.