Abstract: Systems, methods, and other embodiments associated with batch process monitoring are described. One example method may include monitoring an external batch process (e.g. food manufacture, drug manufacture). The method may include collecting data (e.g. material usage, material yield, resource usage, quality results, process parameters, actions performed on batches) from the external batch process. The method may also include generating an XML document based, at least in part, on data collected from the external batch process. The contents of the XML document are to represent a required record that relates to a consumable product manufacturing event. In one example, the record may comply with Title 21 of the United States Code.

Abstract: Systems, methods, and other embodiments associated with database auditing are described. One example method includes generating a first extensible markup language (XML) document using data from a database object. A database object may include data from multiple relational data tables. The method includes generating a second XML document in response to an event causing a change to the database object. The method also includes comparing the first and second XML documents to identify changed values. The method also includes displaying the identified changes.

Abstract: A method of and system for intercepting a transaction instantiated by a database application to determine if an electronic signature is necessary to commit the transaction to the database is disclosed. In one embodiment the method comprises calling an application program interface to raise an event in response to a triggering action generated by the database application; initiating a workflow process that executes a rule to determine if an electronic signature is required to approve the transaction; and if execution of the rule results in a determination that an electronic signature is required for the transaction, instantiating a signature collection process. Some embodiments further comprise obtaining an electronic signature in response to the signature collection process and thereafter, verifying the electronic signature and updating a filed of the electronic record to indicate a valid signature was collected if the electronic signature is verified.

Abstract: A method of and system for collecting an electronic signature for an electronic record stored in a database. In one embodiment the method comprises automatically creating an electronic record from data stored in a plurality of different database tables in response to the occurrence of a predetermined event; storing an instance of the electronic record in a common repository of electronic records that provides an audit trail that cannot be altered or disabled by users of the system; executing a rule associated with the electronic record to determine whether an electronic signature is required to connote review and/or approval of the electronic record; and if execution of the rule results in a determination that an electronic signature is required, marking the instance of the electronic record as unsigned and initiating a request to collect the required electronic signature.

Abstract: A method of and system for searching unstructured data stored in a database. In one embodiment the method comprises storing a plurality of electronic records in a common repository of electronic records in the database that provides an audit trail that cannot be altered or disabled by users of the system where each electronic record comprises unstructured data stored in a character large-object (CLOB) format in a column of a table of the database; creating a security protocol that protects the electronic records against unauthorized access; and creating a query designed to identify electronic records in the database that meet criteria designated in the query. The method further comprises modifying the query in accordance with the security protocol to create a modified query prior to executing the query and running the modified query against the unstructured data.

Abstract: Systems and methods are disclosed herein for verifying the competence of an operator in a manufacturing facility. In one implementation, for example, an operator competence verifying system comprises one or more input/output (“I/O”) devices configured to receive information from a user and provide information to the user. The system also comprises a processing device, which is configured to enable the user to set up a competence profile of an operator in the manufacturing facility. The processing device is further configured to enable the user to define jobs related to handling sensitive material at multiple material handling stages in the manufacturing facility. Also, the processing device is configured to assign training to the operator as needed to meet industry guidelines. The processing device is also configured to enable the user to define competence levels required at each multiple material handling stage.

Abstract: A method of and system for associating an electronic signature with an electronic record in a computer system.

Abstract: Systems, methods, and other embodiments associated with database auditing are described. One example method includes generating a first extensible markup language (XML) document using data from a database object. A database object may include data from multiple relational data tables. The method includes generating a second XML document in response to an event causing a change to the database object. The method also includes comparing the first and second XML documents to identify changed values. The method also includes displaying the identified changes.

Abstract: Systems, methods, and other embodiments associated with batch process monitoring are described. One example method may include monitoring an external batch process (e.g. food manufacture, drug manufacture). The method may include collecting data (e.g. material usage, material yield, resource usage, quality results, process parameters, actions performed on batches) from the external batch process. The method may also include generating an XML document based, at least in part, on data collected from the external batch process. The contents of the XML document are to represent a required record that relates to a consumable product manufacturing event. In one example, the record may comply with Title 21 of the United States Code.

Abstract: A method of and system for collecting an electronic signature for an electronic record stored in a database. In one embodiment the method comprises automatically creating an electronic record from data stored in a plurality of different database tables in response to the occurrence of a predetermined event; storing an instance of the electronic record in a common repository of electronic records that provides an audit trail that cannot be altered or disabled by users of the system; executing a rule associated with the electronic record to determine whether an electronic signature is required to connote review and/or approval of the electronic record; and if execution of the rule results in a determination that an electronic signature is required, marking the instance of the electronic record as unsigned and initiating a request to collect the required electronic signature.

Abstract: A method of and system for searching unstructured data stored in a database. In one embodiment the method comprises storing unstructured data in a column of a database table; allowing a user to identify elements in the unstructured data as indexed elements; creating an intermediate index into the unstructured data from the identified elements; and allowing a user to create queries on the unstructured data using the indexed elements. In some implementations of this embodiment the unstructured data comprises a well-formed XML document stored within a column of a database table. Also, in some implementations the unstructured data is part of an electronic record stored in a common repository of electronic records that provides an audit trail that cannot be altered or disabled by users of the database.

Abstract: A method of and system for searching unstructured data stored in a database. In one embodiment the method comprises storing a plurality of electronic records in a common repository of electronic records in the database that provides an audit trail that cannot be altered or disabled by users of the system where each electronic record comprises unstructured data stored in a character large-object (CLOB) format in a column of a table of the database; creating a security protocol that protects the electronic records against unauthorized access; and creating a query designed to identify electronic records in the database that meet criteria designated in the query. The method further comprises modifying the query in accordance with the security protocol to create a modified query prior to executing the query and running the modified query against the unstructured data.

Abstract: A method of and system for intercepting a transaction instantiated by a database application to determine if an electronic signature is necessary to commit the transaction to the database is disclosed. In one embodiment the method comprises calling an application program interface to raise an event in response to a triggering action generated by the database application; initiating a workflow process that executes a rule to determine if an electronic signature is required to approve the transaction; and if execution of the rule results in a determination that an electronic signature is required for the transaction, instantiating a signature collection process. Some embodiments further comprise obtaining an electronic signature in response to the signature collection process and thereafter, verifying the electronic signature and updating a filed of the electronic record to indicate a valid signature was collected if the electronic signature is verified.

Abstract: A method of and system for associating an electronic signature with an electronic record in a computer system.