Patent ID: 7487182

Claim:
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.