What is SAP GxP?

The term SAP GxP refers to the use of SAP software in highly regulated industries. These include, in particular, pharmaceutical, medical technology and biotechnology industries (also known as the life sciences industry).

In these industries, very specific and strict regulatory requirements apply to products - and therefore also to the processes and systems used to manufacture them. Means in those industries they need to comply with GxP regulations (Good Practice guidelines). Where x can stand for:

·        GMP (Good Manufacturing Practice)

·        GLP (Good Laboratory Practice)

·        GCP (Good Clinical Practice)

·        GDP (Good Documentation Practice)

These guidelines are monitored by regulatory bodies like in the case of pharmaceuticals the FDA (USA) and EMA (Europe) and aim to ensure product quality, safety, and compliance.

SAP GxP includes functions that enable companies to fulfil these requirements. Issues such as data security, traceability (tracing a drug production through so called batch number) and documentation play an important role here.

 

SAP GxP Solutions

SAP offers specialized solutions for regulated industries:

·        SAP S/4HANA Cloud for GxP, Private Edition - A version specifically designed for life sciences with built-in compliance features

·        SAP Quality Requirements Schedule - Additional documentation and audit rights for GxP customers

·        Support for Computer System Validation (CSV) - The regulatory validation process required for IT systems in GxP environments