ABSTRACT
The pharmaceutical industry is obliged to document carefully every single step in the drug manufacturing process. This is one of the mandatory activities to ensure that a drug is safe for use. An Electronic Batch Recording System (EBRS) is a system that creates electronic batch records. However, the system described in this case study does far more. It could be considered a Manufacturing Execution System (MES). The name is given based on the approach. If plant automation is the main driver, the term MES is more often used. EBRS as a term is used more to describe the electronic batch recording capability. Either way, EBRS facilitates efficient documentation by making good use of the possibilities offered by today’s Information Technology (IT). The following case study gives an insight into the business needs leading to the introduction of an EBRS. Furthermore, it describes the system and the realization concept, the system specification, and the approach used for computer system validation.
