SAP SE is a global leader in the development and distribution of enterprise software that is capable of handling all of a company’s business processes. The SAP portfolio features a wide variety of solutions, such as for Enterprise Resource Planning (ERP), Supply Chain Management (SCM), Product Lifecycle Management (PLM), Customer Relationship Management (CRM) and Supplier Relationship Management (SRM).
The most important stand-alone product is SAP ERP (today referred to as ‘Digital Core’), which in 2004 replaced the SAP R/3 business software suite previously in widespread use worldwide. In early 2015, the fourth generation of the business suite was introduced, SAP S/4HANA: this features a modern, in-memory database (HANA) and a browser-based user interface (Fiori).
For the life sciences in particular (pharmaceuticals, medical technology), the SAP suite offers extensive solutions for sector-specific requirements. These are described on SAP’s Life Sciences industry page and in the so-called SAP Industry Portfolio for Life Sciences.
Companies working in the life sciences manufacture pharmaceutical products or medical devices that are subject to a series of legal requirements, some of which are particularly onerous (GAMP, 21 CFR, ISO 13485, etc.). These not only have an impact on the processes to be supported by the application system and the required functionality, but also affect implementation activities and system operations. As a result, life science companies that operate a SAP system must also be able to engage with topics in the fields of GxP compliance and validation.