Endress+Hauser Integrates GMP Annex 11 Revision 1 at its Swiss Center of Competence

The new Good Manufacturing Practice (GMP) annex, annex 11 revision 1 – computerized systems, will commence operations from 30 June 2011.

The reason why annex 11 has been reviewed is because of the higher number of computerized systems in use and in development and their respective permanently increasing complexity.

This annex concerns all computerized systems which are in a GMP compliant environment. The risk management has to be applied throughout the complete lifecycle of the computerized system and takes into account the patient, data integrity (mainly GxP data), safety and the drug’s quality.

A closed cooperation between all concerned parties is highly recommended as well as appropriate qualification (IT staff, system owner, quality management and process owner as examples).

Our center of competence (CoC) for the life sciences industry located in Reinach, Switzerland, has already integrated the different aspects described in the annex 11 revision 1.

The life sciences industry, but particularly suppliers and services providers, are highly concerned: any company having to provide, install, integrate, configure, maintain, document, etc. a computerized system or related services for data processing, must establish formal agreements between user and third party where the responsibilities of each company has to be clearly defined.

Regarding the project phases, the documentation, the validation, concerns for the critical systems and other aspects are detailed and must be conducted according to the specified guidelines. The same approach and set of rules applies for the operational phases (data and data storage, accuracy checks, change controls and security as well as periodic evaluation).

Endress+Hauser’s center of competence for the life sciences industry is committed to serving customers and is ready to face this new challenge.

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