It should be understood that the term “EBR” represents an application and not a separate IT system (cf. EU-GMP Guide; Annex 11 – Glossary: applications). The EBR application (see Figure 1) can be realised on different levels of an automation pyramid.
Figure 1: Automation pyramid with ISA 95 references
Examples of the automation pyramid are shown below; each one in turn includes examples and designates different types of systems and definitions.
The ISA-95 Model (ANSI/ISA-95) is a standard of the International Society of Automation (ISA), with which production processes on these levels can be evaluated. These levels are predefined there as functional hierarchies of the systems from level 0 to level 4 (A+B) (see Figure 1). The evaluation encompasses the functional dataflow, the placement in the predefined hierarchy levels and corresponding object models between demand and production requirements. The ISA 95 model is recommended for analysing and modelling an EBR system, although this model alone is not adequate since it was designed to span different sectors. Therefore, the GMP requirements should be added and assessed in a dedicated manner.
As a rule, EBR applications are realised on the corporate level (ERP), production level (MES) or the process control level (SCADA), or they are offered by suppliers. Suppliers of document management systems (DMS) also sometimes offer EBR functionality. The topic Data Warehouse relates to this. This term is defined as a central database that compiles data from different sources (systems) and puts it into a uniform format (information integration).
However, it is impossible to clearly limit and simply arrange the system types, since the limits are increasingly becoming blurred by convergence strategies of suppliers and the functional scopes vary. For example LIMS, document management, training administration or warehouse management functions are also being offered by some ERP and MES system suppliers. Direct linkage into the SCADA levels (bidirectional), document management systems or archiving systems is also possible.
The appropriate selection must be oriented towards the existing infrastructure, the company-wide IT strategy and the size and/or structure of the company. The EBR supplier must be qualified and evaluated or audited in accordance with Annex 11 (3. Suppliers and Service Providers) or Chapter 7 of the EU-GMP Guide.
EBR applications are widespread on the level of MES systems (Manufacturing Execution System). Such MES systems are encountered as dedicated IT systems, or they are functionally covered in increasing numbers by ERP or SCADA system suppliers; the boundaries here are fluid and partly overlap. Historically, however, the EBR application has been placed in an MES system. The industrial association Manufacturing Enterprise Solutions Association (MESA) prescribes methods and standards for implementation (batch production; lot production), and provides its members with relevant information (e.g. white papers).
The text is an excerpt from GMP Series Electronic Batch Recording for Drugmakers
You will learn all you need to know about:
Don’t miss ordering your copy of Electronic Batch Recording for Drugmakers
comes compliance services, Germany