Automated validation processing and workflow management

Details Automated validation processing and workflow management Automated validation processing and workflow management

2005-03-01

2005-03-01

Picard, Leo (Department: 2125)

Data processing: generic control systems or specific application

Specific application, apparatus or process

Product assembly or manufacturing

C700S109000, C700S103000, C705S001100

Reexamination Certificate

active

06862488

ABSTRACT:
A system and methods to perform automated validation and corresponding workflow management are provided. In an illustrative implementation, the present invention comprises a computing application operating in a computing environment that cooperates with at least one data store. The computing application provides a user interface to accept and display data representative of validation processing and/or the corresponding workflow management surrounding the validation lifecycle. In operation, data is accepted through the user interface and processed by the exemplary computing application to generate one or more validation protocols. Further, validation protocols are stored in cooperating data stores for subsequent execution. The exemplary computing application also maintains processing rules that allow participating users to perform workflow management for efforts required to realize the validation lifecycle.

REFERENCES:
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patent: 20030069894 (2003-04-01), Cotter et al.
patent: 20040158475 (2004-08-01), Juzeszyn et al.
Agalloco et al. “Master,planning and validation: Part 2: System definition” Biopharm; Apr. 2000,vol. 13, No. 4, pp. 34-38.*
Hodgson, “A pratical guide to executing validation protocols”, Biopharm; Apr. 1999,vol. 12, No. 4, pp. 30-32.*
Budihandojo et al. “The future state of computer validation, Part II: Increasing the efficiency of computer validation pratices” Pharmaceutical Technology Europe; Jan. 2002, vol. 14, No. 1, pp. 34-40.

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