Computer validation in a GxP-regulated environment

17 August 2010

pharma technologie journal

Karlsruhe, August 17th, 2010 – The latest edition of the “pharma technologie journal” with the title “Computer validation in a GxP-regulated environment” comments on risk management in GAMP 5 and shows how cost and time can be reduced in validation. Titus Krauss, Director Sales & Marketing at Systec & Services, authors with two co-authors the possibilities to reduce the validation efforts for MES (Manufacturing Execution System) significantly.

"pharma technologie journal" is a publication series which deals with special pharmaceutical-technological subjects in single volumes. In particular, the efficient implementation of GMP requirements in the companies is dealt with. "pharma technologie journal", edited by Concept Heidelberg, is a peer-reviewed journal published twice a year.

The fifth version of the Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture (GAMP® 5), published in February 2008, implemented risk management from ICH Q9 resp. Annex 20 within the validation of computerised systems. Differently from the previous versions that favoured the V-model, the current guide is based on a life cycle approach, starting with the risk-based decision as to whether a system is to be validated and ending with the system’s shutdown.

This new volume, “Computervalidierung im GxP-regulierten Umfeld“ (Computer validation in a GxP-regulated environment) comments on risk management in GAMP 5 and shows how cost and time can be reduced in validation. The individual articles written by professionals from industry, consulting and suppliers cover topics such as current developments in computer systems validation, the involvement of suppliers, operation and maintenance of the validated condition as well as six case reports. In one of these case reports Titus Krauss, Director Sales & Marketing at Systec & Services, authors with two co-authors the possibilities to reduce the validation efforts for MES (Manufacturing Execution System) significantly.

Use Case: Validation of an MES according to GAMP

The pharmaceutical industry abounds in multiple types of MES (Manufacturing Execution Systems) systems; from totally customised versions to perform some focused tasks up to standard configurable products providing an entire palette of functionality. A “Weighing/Dispensing” system is often the first component of MES, which is introduced and later enhanced to encompass the other areas within a plant. Nevertheless, the validation of such systems is a daunting task due to the stringent regulations that dictate the processes within this industry.

In this paper, we propose a methodology derived from the risk-based approach of GAMP® 5 for simplifying the validation process. On the one hand we define an explicit demarcation between the standard product and the customisations and on the other hand we provide insights for the exploitation of the documents and tests performed by the vendors in leveraging the validation process.

Series: pharma technologie journal, 1097
ECV • Editio Cantor Verlag
ISBN 13: 978-3-87193-412-4
language: German
edition / year of publication: 1st edition 2010
extent: 208 pages

For further information:

Systec & Services GmbH
Emmy-Noether-Strasse 9
76131 Karlsruhe
Germany

Titus Krauss
Phone: +49 721 6634-330
Fax: +49 721 6634-333
E-Mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it