ABSTRACT
I. SYSTEM INTEGRATION PROJECT PLAN Using the Purdue Enterprise Reference Architecture (PERA) master validation plan, a detailed project plan can be defined for system integration projects for pharmaceutical manufacturing automation. The plan defines the activities, activity objectives, and tasks for each project phase using the PERA phase definitions, as follows:
Concept and definition Functional requirements specification Detailed design specification Construction Installation Operations and rollout
For each of the phases, a set of activities is defined. These activities have specific tasks that need to be executed for a successful project. Specific system and documentation deliverables have been defined for each phase. The documentation forms the basis of installed system validation as well as planning tools for the next phase. The documentation can also focus on the potential system benefits that demonstrate project progress. Demonstrating progress is an important element of a successful manufacturing project implementation. The project plan will support the Parental Drug Association (PDA) and Pharmaceutical Manufacturers Association (PhARMA) methodologies and is an example of a plan that will support regulatory compliance and system validation.
