Since 1981, Cadmatic Ltd has systematically developed plant design applications for the industry. CADMATIC Software is a powerful 3D plant design software developed especially for the needs of pulp and paper and process industry. Now for the management of the vast documentation needed in the project to built and validate a modern pharmaceutical factory we have developed in the CADMATIC family a program called CADMATIC Pharma.
In CADMATIC Pharma there is a search tree based on four different hierarchical levels. The highest level is called validation level. In this level we describe the categories which are to be validated, process, utilities, clean rooms etc. Next level is system/unit level where all systems and larger units are described, WFI-loop, autoclave etc. In the qualification level which comes after system/unit level the qualification activities, DQ, IQ.. are described and finally in the document level there are specified all documents which belongs to the specified qualification activity of the systems/units.
The search of documents is very easy especially if users have a CADMATIC-3D or similar 3D-model of the production plant. Users just point an equipment in the model and get information if it is an independent unit or if it belongs to some system. After that user is able to start to review what is specified and what is the status of the documentation in the different hierarchical levels. Users can also use one or all of the hierarchical levels to go down into the 3D-model and see what equipment and items are included in the systems. It is easy to plot a 3D-axonometric drawing of the system or a drawing showing for example all the welds in the cold WFI-loop. User can as well pick up a protocol showing the signal tests done for that loop.
Due to the systematic way CADMATIC Pharma is working it is easy to design what will be included in the different validation and qualification activities. Users can start to design validation activities in the early beginning of the project and make the plans more accurate continuously during the different phases of the project. This makes it possible also to allocate and manage the resources needed during the different qualification and validation phases.
While You have during Your investment project built a structured CADMATIC Pharma validation data base the revalidation of the different parts of Your production plant will be much more easier than before. As a prerequisite of a successful revalidation is that during maintenance all the documentation and the plant 3D-model is kept updated. This is why CADMATIC 3D has been linked to maintenance programs, such as IFS, SAP R/3 and of course our own CADMATIC Maintenance.
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