Tuesday, March 22, 2011

Process Automation and Computer System Validation





It is well established that process automation systems need independent validation of the computer system to meet GMP requirements. With good planning, testing, procedures, and documentation, almost any computer system can be validated. The DeltaV value proposition is a lower cost of initial system validation by virtue of its integrated batch automation design. The DeltaV system lowers the computer systems validation cost by offering a single integrated system rather than a component-based architecture highlighted by a “class-based” configuration technique. Class-based configuration reduces the overall amount of documentation and engineering that needs to be done. Below are the specifics on how the DeltaV technology offers advantages in the area of validation.
Most automation systems of PLC technologies are component-based and require the configuration, installation, testing, and documentation of separate packages. This includes the engineering required to interface / link the various software applications to each other.

In the area of validation, less is better, Less engineering = Less validation.
The DeltaV system reduces validation cost by eliminating the need to interface and configure different software packages to each other. The following items are specific areas where this advantage is realized:
• Human/Machine Interface. The DeltaV system’s HMI shares a common database with the control modules and I/O. This eliminates the need to define tags at the HMI and map them to the controller tags and I/O. `
• Batch History. The DeltaV Batch History requires NO CONFIGURATION. Since the DeltaV Historian was designed as an integrated capability, once a recipe is executed with the DeltaV Batch Executive, the Batch Executive generates events. The events are then stored in the Batch Historian and are organized by batch ID according to the S88 model. Many batch history packages have to be extensively configured to recognize when batch events are occurring from triggers in the process. The DeltaV approach provides less configuration, less documentation, less engineering, and, hence, less validation.
• Continuous History. The DeltaV Continuous Historian was designed as an integrated feature. DeltaV Continuous History configuration requires selection of the DeltaV attributes for history assignment. A separate tag database would need to be mapped and configured to other system tag databases with component-based system historians. As stated before, less engineering, less configuration, less documentation all result in less validation.



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