Enterprise framework and applications supporting meta-data and data traceability requirements
First Claim
Patent Images
1. A method of managing data within an enterprise-wide, web-based framework said method comprising the steps of:
- marking up data to be managed within the framework with predefined types of meta-data;
submitting the marked up data to the framework;
assigning a unique identifier to be associated with the data and a location in which the data is to be stored;
storing the unique identifier and location for subsequent access to the data;
assigning a unique primary key to each item of meta-data associated with the data;
storing each item of meta-data with its unique primary key, type of meta-data and the unique identifier connecting the item of meta-data with the data;
providing a hierarchy of dossiers into which artifacts, defined by the meta-data stored, are classified;
defining at least one specified role, team or users;
defining which of the dossiers each user, role or team will be entitled to access;
defining a level of entitlement that each user, role and team has with regard to each dossier, wherein a level of entitlement may be selected from a read only level;
a read and edit level;
a read, edit and submit new data level;
a read, edit and export data level; and
a read, edit, submit new data and export level;
allowing a user, role or team access to only those dossiers which the user, role or team has been defined to be entitled to, and only at the entitlement level defined;
allowing users, roles or teams which are entitled to write to a dossier containing the stored meta-data linked to the submitted data to submit new versions of the data, write annotations to the data, or mark the data for deletion;
generating an event for each new version of the data, each annotation to the data, or each marking of the data for deletion;
wherein each of these functions is stored with the mete-data associated with the data and is linked to the unique identifier of the data;
storing each event with an associated time stamp;
wherein the submission of marked up data generates an event, and wherein other predefined manipulations of the data generate events; and
generating a traceability report based on the events, thereby creating a history of all events that have occurred with regard to the data.
1 Assignment
0 Petitions
Accused Products
Abstract
An application adapted to run within an enterprise wide, web-based framework which provides reusable services and facilities such as security, meta-data management and traceability of data and a framework supporting the same. The framework supports decision making across the value chain, with an emphasis on the meta-data needed for decision making. The framework can support the activities of a virtual organization (internal or external) and the inevitable variations in data types, file formats etc. without requiring massive integration between the various sources of data involved.
72 Citations
26 Claims
-
1. A method of managing data within an enterprise-wide, web-based framework said method comprising the steps of:
-
marking up data to be managed within the framework with predefined types of meta-data; submitting the marked up data to the framework; assigning a unique identifier to be associated with the data and a location in which the data is to be stored; storing the unique identifier and location for subsequent access to the data; assigning a unique primary key to each item of meta-data associated with the data; storing each item of meta-data with its unique primary key, type of meta-data and the unique identifier connecting the item of meta-data with the data; providing a hierarchy of dossiers into which artifacts, defined by the meta-data stored, are classified; defining at least one specified role, team or users; defining which of the dossiers each user, role or team will be entitled to access; defining a level of entitlement that each user, role and team has with regard to each dossier, wherein a level of entitlement may be selected from a read only level;
a read and edit level;
a read, edit and submit new data level;
a read, edit and export data level; and
a read, edit, submit new data and export level;allowing a user, role or team access to only those dossiers which the user, role or team has been defined to be entitled to, and only at the entitlement level defined; allowing users, roles or teams which are entitled to write to a dossier containing the stored meta-data linked to the submitted data to submit new versions of the data, write annotations to the data, or mark the data for deletion; generating an event for each new version of the data, each annotation to the data, or each marking of the data for deletion;
wherein each of these functions is stored with the mete-data associated with the data and is linked to the unique identifier of the data;storing each event with an associated time stamp;
wherein the submission of marked up data generates an event, and wherein other predefined manipulations of the data generate events; andgenerating a traceability report based on the events, thereby creating a history of all events that have occurred with regard to the data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
-
-
14. A method of managing data within an enterprise-wide, web-based framework, said method comprising the steps of:
-
marking up data to be managed within the framework with predefined types of meta-data; submitting the marked up data to the framework; assigning a unique identifier to be associated with the data and a location in which the data is to be stored; storing the unique identifier and location for subsequent access to the data; assigning a unique primary key to each item of meta-data associated with lie data; storing each item of meta-data with its unique primary key, type of meta-data and the unique identifier connecting the item of meta-data with the data; providing a hierarchy of dossiers into which artifacts, defined by the meta-data stored, are classified; defining at least one specified role, team or users; defining which of the dossiers each user, role or team will be entitled to access; defining a level of entitlement that each user, role and team has with regard to each dossier, wherein a level of entitlement may be selected from a read only level;
a read and edit level;
a read, edit and submit new data level;
a read, edit and export data level; and
a read, edit, submit new data and export level;allowing a user, role or team access to only those dossiers which the user. role or team has been defined to be entitied to, and only at the entitlement level defined; searching on the stored meta-data associated with artifacts selected by a user from a dossier among those dossiers which the user is entitled to, thereby defining a subset of the data collected in the dossier; and assembling select portions of the subset of data into a template, wherein the template is 21 C.F.R. 11 compliant.
-
-
15. A method of managing data within an enterprise-wide, web-based framework, said method comprising the steps of:
-
marking up data to be managed within the framework with predefined types of mete-data; submitting the marked up data to the framework; assigning a unique identifier to be associated with the data and a location in which the data is to be stored; storing the unique identifier and location for subsequent access to the data; assigning a unique primary key to each item of meta-data associated with the data; storing each item of meta-data with its unique primary key, type of meta-data and the unique identifier connecting the item of meta-data with the data; providing a hierarchy of dossiers into which artifacts, defined by the meta-data stored, are classified; defining at least one specified role, team or users; defining which of the dossiers each user, role or team will be entitled to access; defining a level of entitlement that each user, role and team has with regard to each dossier, wherein a level of entitlement may be selected from a read only level;
a read and edit level;
a read, edit and submit new data level;
a read, edit and export data level; and
a read, edit, submit new data and export level;allowing a user, role or team access to only those dossiers which the user, role or team has been defined to be entitled to, and only at the entitlement level defined; searching on the stored meta-data associated with artifacts selected by a user from a dossier among those dossiers which the user is entitled to, thereby defining a subset of the data collected in the dossler; and assembling select portions of the subset of data into a template, wherein the template is formatted to comply with requirements for the submission of an Investigational New Drug submission to the FDA.
-
-
16. An application adapted to run within an enterprise wide, web-based framework, said application comprising:
-
a schema requiring predefined types of mete-data to be marked up with new data to be submitted to the framework; means for assigning a unique identifier to each new data submitted; means for assigning an address outside of the framework where the new data will be stored; means for storing the unique identifier associated with the address; means for assigning primary keys to each item of meta-data associated with the new data and storing each item of meta data associated with its primary key, type of meta-data and a foreign key which points to the unique identifier; means for creating a hierarchical classification of dossiers; means for assigning data to a selected dossier; means for defining user entitlement to each dossier created, wherein a system administrator establishes users, roles and teams and defines which of the dossiers each specific user, role or team is entitled to access; means for preventing access to data in a dossier which a user, role or team is not entitled to access; and means for identifying and searching on information that a user wishes to associate with data selected from a dossier that the user is entitled to, wherein said means for identifying and searching comprises means for formulating a Boolean search based on a preselected dossier or group of dossiers and one or more types of stored meta-data, annotations associated with stored meta-data or stored meta-data and said annotations. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
-
Specification