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Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes

  • US 20060276923A1
  • Filed: 08/14/2006
  • Published: 12/07/2006
  • Est. Priority Date: 05/06/2004
  • Status: Active Grant
First Claim
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1. ) A method of integrating a computer product with a pharmaceutical manufacturing system said method comprising, a) contacting the computer product to a software device used in pharmaceutical manufacture;

  • b) monitoring the data generated by the software device used in pharmaceutical manufacture;

    c) maintaining the data over time to provide a historical record;

    d) analyzing the historical record to provide a risk-based assessment in case of failure;

    e) taking corrective action to obviate the failure.

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