×

Systems and methods for managing the development and manufacturing of a drug

  • US 7,487,182 B2
  • Filed: 05/08/2006
  • Issued: 02/03/2009
  • Est. Priority Date: 01/23/2001
  • Status: Active Grant
First Claim
Patent Images

1. A method for monitoring a chemical process for the development and manufacture of a drug, the method comprising:

  • recording information about the chemical process using a user interface comprising one or more options including an administration option that sets a plurality of user preferences associated with the chemical process;

    a people management option that defines a user role in said chemical process;

    an organization option that defines an organizational structure of an organization that runs said chemical process;

    an equipment option that defines equipment used in said chemical process;

    a material option that controls a chemical used in said chemical process; and

    a process option that defines a chemical reaction in the chemical process;

    assigning the recorded information to a plurality of data dimensions, wherein each option corresponds to at least one data dimension;

    determining one or more permanent correlations between data dimensions in the plurality of data dimensions wherein each permanent correlation spans a particular time and corresponds to a particular event in the monitoring of the chemical process;

    storing the one or more permanent correlations;

    determining a context to the information;

    searching the one or more permanent correlations between data dimensions in the plurality of data dimensions in response to the context;

    retrieving information from the one or more permanent correlations and the plurality of data dimensions about the monitoring of the chemical process in view of the context;

    using the information to generate an electronic product history record or electronic development record for inclusion in a submission to a regulatory agency comprising the Food and Drug Administration, the Trade and Tax Bureau, or a state or federal agency involved in the regulation of the development or manufacture of drugs; and

    including the electronic product history record or the electronic development record in the submission to the regulatory agency for regulatory approval of the drug.

View all claims
  • 3 Assignments
Timeline View
Assignment View
    ×
    ×