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VDI/VDE 3516 Blatt 6

Validation in GxP area - Validation of interfaces

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Englischer Titel

Validierung im GxP-Umfeld - Validierung von Schnittstellen

Engl. VDI/VDE-Gesellschaft Mess- und Automatisierungstechnik
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In many validation projects in the IT environment, the different interests of quality management, the suppliers involved and the operators of the systems with regard to interfaces and data exchange are not adequately taken into account. Therefore, the general procedures for the validation of computer-based systems were reviewed for this standard and a generic validation approach explicitly developed for interfaces that supports the specification, risk assessment and verification of interfaces. The standard adds a scalable validation approach for interfaces of any complexity to the existing rules and specification documents. Concrete instructions and assistance are given to understand the interface in its process and system context and to select the appropriate validation approach. The focus is on interfaces and the integrity of the data to be transferred.

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