Systems and methods for managing the development and manufacturing of a drug
First Claim
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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.
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Abstract
Graphical user interfaces, computer readable media, and computer systems for monitoring a chemical process. An administration module sets a plurality of user preferences associated with the chemical process. A people management module defines a user role in the chemical process. An organization module defines an organizational structure of an organization that runs the chemical process. An equipment module defines equipment used in the chemical process. A material module controls a chemical used in the chemical process. A process module defines a chemical reaction in the chemical process.
55 Citations
21 Claims
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1. A method for monitoring a chemical process for the development and manufacture of a drug, the method comprising:
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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 Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A computer program product, tangibly embodied in a machine-readable storage device, including instructions operable to cause data processing apparatus to:
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record information about a chemical process, the information being received through a user interface comprising one or more options including an administration module that sets a plurality of user preferences associated with the chemical process;
a people management module that defines a user role in said chemical process;
an organization module that defines an organizational structure of an organization that runs said chemical process;
an equipment module that defines equipment used in said chemical process;
a material module that controls a chemical used in said chemical process; and
a process module that defines a chemical reaction in the chemical process;assign the recorded information to a plurality of data dimensions, wherein each option corresponds to at least one data dimension; determine 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; store the one or more permanent correlations; determine a context to the information; search the one or more permanent correlations between data dimensions in the plurality of data dimensions in response to the context; retrieve 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; use 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 include the electronic product history record or the electronic development record in the submission to the regulatory agency for regulatory approval of the drug.
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21. A computer system for monitoring a chemical process, the computer system comprising a memory coupled with a central processing unit, the memory comprising instructions operable to cause the central processing unit to:
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record information about a chemical process, the information being received through a user interface comprising one or more options including an administration module that sets a plurality of user preferences associated with the chemical process;
a people management module that defines a user role in said chemical process;
an organization module that defines an organizational structure of an organization that runs said chemical process;
an equipment module that defines equipment used in said chemical process;
a material module that controls a chemical used in said chemical process; and
a process module that defines a chemical reaction in the chemical process;assign the recorded information to a plurality of data dimensions, wherein each option corresponds to at least one data dimension; determine 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; store the one or more permanent correlations; determine a context to the information; search the one or more permanent correlations between data dimensions in the plurality of data dimensions in response to the context; retrieve 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; use 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 include the electronic product history record or the electronic development record in the submission to the regulatory agency for regulatory approval of the drug.
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Specification