ABSTRACT
Today, many automation projects are introducing commercially available enterprise resource planning (ERP), manufacturing execution systems (MES), distributed control systems (DCS), and programmable logic controllers (PLC) applications into pharmaceutical manufacturing. Existing mission-critical systems must be included in the new system projects. Regulatory compliance adds the complexity and effort of validation to the project. System planning for these systems must include how to support these validated systems that may reside on different hardware platforms with different operating systems. System development life cycle (SDLC) methodologies provide an excellent framework for these computerbased projects. System architecture is a more encompassing term for an SDLC. In the literature (I) there are references to different architectural types or models, such as the following:
Type I: Physical components or collections of principles, models, standards, and guidelines
Type 2: Life cycle identification for integrated systems. Type 1 architectures are typically referenced as components.
