Method and apparatus for process control validation

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364419, 364580, G06G 748

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active

050797310

ABSTRACT:
A process control and simulator system, such as for use in the manufacture of pharmaceutical products, includes a process control computer which commands and responds to the operation of the process input/output hardware. A simulator computer commands the operation of simulator input/output hardware. The process hardware and simulator hardware are connected by field lines which transfer signals that correspond to the signals that would be produced in actual production operations. The software in the simulator computer not only produces the simulation functions but in addition monitors the outputs from the simulator input/output hardware and records these outputs during the simulation process. The commands produced by the simulator computer, in response to the simulator input/output hardware outputs, are likewise monitored and recorded in a documentation file within a disk drive of the simulator computer. This documentation file serves to document the operation of the process control computer, process hardware, simulator computer and simulator input/output hardware for the purposes of providing validation of the system operation.

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patent: 4494191 (1985-01-01), Itoh
patent: 4613952 (1986-09-01), McClanahan
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patent: 4870561 (1989-09-01), Love et al.
Fry, Pharmaceutical Engineering, "FDA Regulation of Computer Systems in Drug Manufacturing," Sep./Oct. 1988; vol. 8, No. 5.
Miller, "Process Control Validation," Presented at Computer Systems Validation Seminar, Oct. 12-13, 1988.

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