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US 7,444,197 B2Granted
Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes
AssigneeSMP Logic Systems LLC
InventorShane M. Popp
Life of this patent
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Abstract
Methods, systems, and software program for validation of pharmaceutical manufacturing processes and quality assurance process are described and disclosed herein. Consequently, the methods provide a means to perform validation on an integrated level whereby the quality control unit can ensure data and product integrity and minimize cost.
Claims6
A method for monitoring a pharmaceutical manufacturing process, said method comprising:
- a) deriving an algorithm implemented in computer executable instructions that performs data analysis on said pharmaceutical manufacturing process;
- b) performing “logic analysis” on said algorithm;
- c) performing “software safety code analysis” on said algorithm;
- d) performing “software safety design analysis” on said algorithm;
- e) performing “software safety requirements analysis” on said algorithm;
- f) performing “software safety test analysis” on said algorithm;
- g) integrating the said algorithm into a pharmaceutical manufacturing process whereby actual monitoring of the manufacturing process is attained.
4 more elements
Dependencies are inferred from the claim text.