A Smart Manufacturing Compliance Architecture of Electronic Batch Recording System (eBRS) for Life Sciences Industry

The paradigm shift brought about by smart manufacturing or Industrie 4.0 has posed threefold challenges to electronic batch recording system (eBRS) in Life Sciences Industry: 1) the structure of the data should be informative and standard for interoperate using information models, 2) administration of synchronization between physical world and cyber world for smart decision making and optimization using cyber physical system (CPS) and 3) so-called digital manufacturing operations management (digital MOM) characterized by decentralization, comprehensive collaboration and servitization shall be implemented. Under the new situations of smart manufacturing or Industrie 4.0, the requirements from information models, CPS and digital MOM will become the most principal criteria to be considered for future eBRS/MES and other operations management information system in shop floor. To fulfill these demands, an approach combining ISA95/88 hybrid model with activities ontology and variant domain-driven design for SOA-based eBRS development has been presented. An eBRS software platform has been developed on the theoretical basis and applied to a specific application scenario of Lyophilized Injection Production for verifying its feasibility purpose.