Figure 6. Enterprise Level Computer Protocol Integration
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Table 5. Disadvantages and Advantages of Enterprise Level Computer Protocol Integration
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Figure 6 shows data being passed between an OPC client-server on the Rockwell Automation PCS directly to the Metasys for Validated
Environments workstation, which has a built-in OPC server. Data from Levels 0-2 have risen through the architecture and reside
at Level 3, the enterprise level. These data are available to be shared, and there is no reference to which protocol is used
because OPC represents data obtained by the protocol driver inside the application.
Database Integration
The highest degree of integration is at the database level. Database integration allows data to be gathered independently
and then exchanged (Figure 7). Typically, open database connectivity (ODBC), a Microsoft technology, can be used to exchange
data between relational databases. Databases that support this exchange include MS Sequel and Oracle. Not all original equipment
manufacturers (OEMs) support open, relational database structures. When dealing with OEMs that offer only proprietary database
solutions, budget extra money for database integration.
Figure 7. Database Integration
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Table 6. Disadvantages and Advantages of Database Integration
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Another very common method of database integration is creating a single master database integrating all system data. The advantage
of this approach is the reduction in operational costs and maintenance. The key here is ensuring that data is kept intact
and secure throughout the integration. Integration is pointless if the data are not reliable or they are not accessible to
FDA auditors.
FACILITY INTEGRATION EXAMPLE
Let us apply these alternatives to the previously introduced model facility, which housed production and packaging lines,
some warehouse space, offices, common spaces, and a cafeteria. Assuming that this facility has been designed to provide effective
physical system boundaries, our goal is to attain the level of integration needed to satisfy facility control and operational
requirements while addressing FDA's data retrieval and records retention rules — all at a reasonable cost. As you can imagine,
this can be a daunting task, but it is almost always achievable.
We will implement a PLC solution for the process line and a BMS for HVAC. This will give us excellent control of both the
production process and HVAC by systems that are fit for purpose. It will also allow us to take advantage of the process-specific
algorithms designed to make system operation easier.
In addition, this gives us the best physical system separation for defining system boundaries. When a single system on a single
network is forced to cover multiple applications across the entire facility, it can be difficult to draw the system boundaries.
Physically separating the GMP network and the non-GMP network creates clear system boundaries.
We must determine how our systems need to communicate to accomplish each of the following goals:
- integrating environmental data to lot and batch production data
- integrating alarm data to the process floor
- sending environmental data to the data historian for record retention.
Then we can identify the best integration approach and implement the solution in a way that provides maximum reliability while
minimizing (or at least mitigating) risk of data loss, FDA observations of noncompliance, or production shutdowns.
The non-GMP BMS is not linked with any other system. It is a stand-alone application that controls the environment in the
building's cafeteria, hallways, offices, and interstitial spaces. In some scenarios, this non-GMP BMS is integrated with other
non-GMP systems, such as security and access control systems and fire monitoring systems, but this paper will focus primarily
on the GMP side of the facility and network.
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