The following main requirements determine the architecture of PAS-X:
Support for the development of product software, i.e. software that
is provided "out of the box" as a complete standard system
is implemented at numerous customer sites
is continually expanded and improved
needs to be updateable at low cost so that the customers are able to benefit from im-provements to the standard system, even under GMP conditions
Support for the development of product variations in order to satisfy application-specific and/or customer-specific requirements, while at the the same time
maximizing the shared standard software portions and
minimizing the application-specific or customer-specific software portions in order to maintain a cost-effective updateability
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Support for start-up solutions, which can be upgraded to full-scope solutions
All of these requirements are important, especially for those customers that intend a global roll-out of a standard MES at all of their production sites.
Component Model as the Basis for the PAS-X Architecture
In order to meet all these requirements, we have developed and consistently implemented a com-ponent model for PAS-X.
The software architecture of PAS-X is based on a huge number of components that communicate with each other via specific services and cover up all of the implementation details.
Basic Components providing the basic services that are generally needed (Audit Trail, Elec-tronic Signature, User Management, Workflow Management, etc.)
Standard Components providing standard MES services for the pharmaceutical industry (Weighing & Dispensing, Electronic Batch Recording, Material Tracking, etc.)
Application-specific Components providing special services for pharmaceutical and biotech environment, API, etc. (Packaging, Fill & Finish, etc.)