« PrécédentContinuer »
United States Patent m
Miller et al.
 METHOD AND APPARATUS FOR PROCESS CONTROL VALIDATION
 Inventors: G. Raymond Miller, Burleson; Paul E. Morgan, Evennan, both of Tex.
 Assignee: Alcon Laboratories, Inc., Fort Worth, Tex.
 Appl. No.: 422,615
 Filed: Oct 17,1989
 Int. CI.' G06G 7/48
 U.S. CI 364/578; 364/419;
 Field of Search 364/578, 920, 933.8,
364/192, 149, 151, 221.2, 916.3, 419, 580, 188;
 References Cited
U.S. PATENT DOCUMENTS
4,408.291 10/1983 Gunzberg et al 364/900
4,484,266 11/1984 Becker et al 364/200
4,494,191 1/1985 Itoh 364/200
4,613,952 9/1986 McClanahan 364/578
4,713,756 12/1987 Mackiewicz et al 364/200
4,870,561 9/1989 Love et al 364/192
Fry, Pharmaceutical Engineering, "FDA Regulation of Computer Systems in Drug Manufacturing," Sep./Oct. 1988; vol. 8, No. 5.
Miller, "Process Control Validation," Presented at
[li] Patent Number: 5,079,731  Date of Patent: Jan. 7,1992
Computer Systems Validation Seminar, Oct. 12-13, 1988.
Primary Examiner—Parshotam S. Lall
Assistant Examiner—Ellis B. Ramirez
Attorney, Agent, or Firm—Richards, Medlock &
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.
9 Claims, 4 Drawing Sheets