WO2002010970A2 - Document management and publication using reusable packages and components - Google Patents
Document management and publication using reusable packages and components Download PDFInfo
- Publication number
- WO2002010970A2 WO2002010970A2 PCT/GB2001/003395 GB0103395W WO0210970A2 WO 2002010970 A2 WO2002010970 A2 WO 2002010970A2 GB 0103395 W GB0103395 W GB 0103395W WO 0210970 A2 WO0210970 A2 WO 0210970A2
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- WO
- WIPO (PCT)
- Prior art keywords
- document
- reusable
- components
- descriptors
- plural
- Prior art date
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Classifications
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
- G06F16/90—Details of database functions independent of the retrieved data types
- G06F16/93—Document management systems
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F40/00—Handling natural language data
- G06F40/10—Text processing
Definitions
- the present invention is directed to methods, systems, and computer program products for document management and more particularly, methods, systems, and computer program products for document management and publication using reusable packages and components.
- Adossierss The regulatory submissions (hereinafter referred to as Adossierss) required to maintain current product licenses and enter new markets are extensive. As the number of products and markets increases, the challenges increase accordingly.
- Commercially available document management systems are adaptable to assist in the production of regulatory dossiers. Such systems provide for the maintenance of a repository of documentation that form the basis for a dossier.
- DOCUMENTUM One commercially available document management system is DOCUMENTUM, which provides (1) a mechanism for maintaining a repository of documents, and (2) tools for publishing documents (e.g., dossiers) from the repository.
- DOCUMENTUM make use of commercially available database management systems (DBMSs) such as ORACLE, SYBASE, or MICROSOFT SQL SERVER to maintain information on the documents being managed.
- DBMSs database management systems
- ORACLE ORACLE
- SYBASE SYBASE
- MICROSOFT SQL SERVER MICROSOFT SQL SERVER
- WORD WORD
- WORDPERFECT standard word processing formats
- United States patents 5,734,883 and 5,963,967 disclose drug document production systems making use of templates to create documents and managing database information pertaining to the documents.
- the challenges presented in creating very large dossiers of 50,000 pages or more required by regulators for a new drug application (NDA) are quite different than those presented by the regulatory requirements to maintain current products or to enter new markets with previously approved products.
- dossiers required for renewals, re-registration, or first registration of approved products in new markets are 1,000-2,000 pages, as compared to the 50,000 pages required for a NDA.
- a large pharmaceutical company may need to generate 1,000 or more of these smaller dossiers on any given year.
- the challenge is to develop an approach that will facilitate the compilation of dossiers for approved products from an existing repository of approved and up-to-date documentation.
- one object of the present invention is to provide an approach for efficiently reusing and repackaging approved and up-to-date submission information for renewals, re-registration, and first registrations in new markets.
- a further object of the present invention is to provide a secure repository for the reusable submission information.
- a further object of the present invention is to provide an ability to perform an impact analysis as to which elements of a document hierarchy are impacted by a particular change to any given element in that hierarchy.
- a further object of the present invention is to provide logical groupings of approved and up-to-date document components that could be utilized in a distributed organization.
- Figure 1 is a schematic diagram of an electronics portion of the workstations used in the system
- Figure 2 is a block diagram showing an overall system configuration for one embodiment of the present invention
- Figure 3 is a block diagram showing mechanisms of a client work station and a document component server shown in Figure 2;
- Figure 4 is an exemplary folder hierarchy showing the concept of component scope
- Figure 5 is a block diagram showing the hierarchical relationships between objects used in the present invention.
- Figure 6 is a state transition diagram showing the life cycle of a component
- Figure 7 is a state transition diagram showing the life cycle of a data package
- Figure 8 is a state transition diagram showing the life cycle of a dossier
- Figure 9 is a block diagram showing an exemplary logical grouping of objects for one embodiment of the present invention.
- Figure 10 is a block diagram showing an exemplary scope of the impact of a change to a component for one embodiment of the present invention
- Figure 11 is a block diagram showing the exemplary creation of multiple dossiers from existing objects using one embodiment of the present invention.
- Figure 12 is a flow diagram of a process to create a new dossier
- Figure 13 is a flow diagram of a process to assess the impact of a change to an object.
- FIG. 1 is a schematic illustration of a computer system for document management and publication using reusable packages and components.
- a computer 100 implements the method of the present invention, wherein the computer housing 102 houses a motherboard 104 which contains a CPU 106, memory 108 (e.g., DRAM, ROM, EPROM, EEPROM, SRAM, SDRAM, and Flash RAM), and other optional special purpose logic devices (e.g., ASICs) or configurable logic devices (e.g., GAL and reprogrammable FPGA).
- the computer 100 also includes plural input devices, (e.g., a keyboard 122 and mouse 124), and a display card 110 for controlling monitor 120.
- the computer system 100 further includes a floppy disk drive 114; other removable media devices (e.g., compact disc 119, tape, and removable magneto-optical media (not shown)); and a hard disk 112, or other fixed, high density media drives, connected using an appropriate device bus (e.g., a SCSI bus, an Enhanced IDE bus, or a Ultra DMA bus). Also connected to the same device bus or another device bus, the computer 100 may additionally
- compact disc reader 118 a compact disc reader/writer unit (not shown) or a compact disc jukebox (not shown).
- compact disc 119 is shown in a CD caddy, the compact disc 119 can be inserted directly into CD-ROM drives which do not require caddies.
- a printer 23 in Figure 2 also provides printed listings for impact analysis of changes to document components.
- the system includes at least one computer readable medium.
- Examples of computer readable media are compact discs 119, hard disks 112, floppy disks, tape, magneto-optical disks, PROMs (EPROM, EEPROM, Flash EPROM), DRAM, SRAM, SDRAM, etc.
- the present invention includes software for controlling both the hardware of the computer 100
- Such software may include, but is not limited to, device drivers, operating systems and user applications, such as development tools.
- Such computer readable media further includes the computer program product of the present invention for document management and publication using reusable packages and components.
- the computer code devices of the present invention can be any combination of hardware and software.
- interpreted or executable code mechanism including but not limited to scripts, interpreters, dynamic link libraries, Java classes, and complete executable programs.
- the system includes a network LI including a client workstation 20, a document component server 21, a document component database 22, and a printer 23.
- the document component database 22 is a digital repository that may be implemented, for example, through a commercially available relational data base management system (RDBMS) based on the structured query language (SQL) such as ORACLE, SYBASE, INFORMIX, or MICROSOFT SQL SERVER, through an object- oriented database management system (ODBMS), or through custom database management software.
- the document component database 22 contains all information of interest on the objects being maintained by the system.
- the document component database includes information on the type of the object (e.g., component, data package, dossier), the name of the object, the status of the object, as well as other descriptive information such as important dates from the object's life cycle.
- Data in the document component database 22 is maintained by processes on the document component server 21.
- the document component database 22 may reside on a storage device of the document component server 21, or reside on another device connected to the document component server 21, for example by way of a local area network LI or other communications link such as a virtual private network, wireless link, or internet-enabled link.
- the client workstation 20 communicates with the document component server 21, for example by way of a local area network LI, although other communications links such as a virtual private network, wireless link, or internet-enabled link may be used as well.
- the client workstation 20 and the document component server 21 interact with the document component database 22 through various software applications.
- the information maintained in the document component database 22 may be accessed through a commercially available document management software application such as DOCUMENTUM.
- Other tasks may interact with the document component database 22 through custom application software to provide features not available through commercially available document management applications.
- the user is able to create document components that get cataloged to the document component database 22 by the document component server 21.
- ML Maintenance Library
- Information pertaining to the packages created by ML is also stored in the document component database 22 by the document component server 21 as the result of commands issued by a user of the client workstation 20.
- the system also includes a printer 23, or other output devices for use in creating deliverable products, or outputting reports to facilitate the document management process.
- a printer 23 or other output devices for use in creating deliverable products, or outputting reports to facilitate the document management process.
- FIG. 3 shows the mechanisms implemented by the client workstation 20 and the document component server 21 in greater detail.
- the client workstation 20 and the document component server 21 include a document management user interface 30.
- the user of a client workstation 20 interacts with the system through the document management user interface 30.
- the document management user interface 30 presents information to, and receives information from, the user of the system and provides that information to the document component packaging mechanism 31 and the document management mechanism 32 which will then manipulate or display the information in the document component database 22 according to the user's direction.
- the input/output mechanism 33 provides a mechanism through which the ML software and the document management software can interact with external components. For example, the input/output mechanism 33 allows the client workstation 20 to connect to the network LI through a remote connection.
- the document management user interface 30 provides information and prompts to the user through the CRT 120, and the user provides input to the system through the keyboard 122 and mouse 124.
- the document management user interface 30, the document component packaging mechanism 31, and the document management mechanism 32 reside in the various memory elements of the computer 100 and cause the CPU 106 to process the information received from the external devices and the user to provide the desired functionality, displays, and output.
- Figure 4 illustrates the concept of scope as implemented through the document management mechanism 32.
- document components are organized by the document management mechanism 32 into groups (e.g., hierarchical folders).- Components that are contained in higher level groups apply to all groups subordinate to that group in the hierarchy unless the subordinate group contains the same component as determined by the component name. Therefore, as shown in Figure 4, Component C exists in FOLDER 3, as well as FOLDERs 4B and 4C.
- FOLDER 3 is not in FOLDER 4A since FOLDER 4A contains a component with the same name as Component C. FOLDER 4A, then, contains the same components as FOLDER 3, with the exception of a different version of Component C.
- the version of Component C that is in FOLDER 4A would have more specific content than the version of Component C contained in FOLDER 3.
- the concept of scope facilitates component reuse, since many dossiers contain many common components. Different versions of the same dossiers, for example, could be created by simply including different versions of the components where the dossier differences are isolated.
- the three main object types of the present invention are dossiers, data packages, and components.
- Components are simple documents that are typically created with a standard word processing application such as WORD or WORDPERFECT. However, components may also be other formats including, but not limited to, portable document format (PDF) or tag image file format (TIFF).
- PDF portable document format
- TIFF tag image file format
- the content of the components may be generic or specific. Generic components may be used in many data packages or dossiers, whereas specific components may be only used in a single data package or dossier.
- Dossiers are virtual documents that group together, in a specific order, both data packages and components, and place the content in the order required by the user.
- the dossiers have to be customized according to the type of submission, market, and/or country.
- the user When creating dossiers, the user must be sensitive to the fact that components and data packages are intended for reuse, and therefore, cannot be modified to create a particular dossier. Therefore, when a dossier is being prepared for publishing, a copy of all the components will be made, so that dossier-specific customization may be niade without impacting the reusability of the components.
- the publication of a dossier by the ML system involves not only the determination of which components and data packages are to be included, but also considerable reformatting.
- a dossier published by the ML system includes each of the individual components making up the text of the dossier, but also is formatted to include, for example, proper pagination as a single document, a table of contents, as well as header and footer information throughout the document.
- a formatted file e.g., a PDF file containing a concatenation of the individual components paginated as a single document with a table of contents
- the document component packaging mechanism 31 maintains the data packages and stores information defining the data packages in the document component database 22. As part of the document management process, the present invention enforces life cycles on each of the three main object types of the system (i.e., dossiers, data packages, components).
- Figure 6 shows a life cycle for a component object in one embodiment of the present invention.
- a component may be imported into the ML system in either a state of "DRAFT” or "APPROVED.” New components that are created within the ML system are created in an initial state of "DRAFT.” A component may remain in the state of "DRAFT” for several iterations before advancing to the state of "CHECKED,” for example, as the component is being originally drafted.
- the normal life cycle for a component in the ML system is from "DRAFT” to "CHECKED” to "APPROVED” to "LIVE.”
- rules could be written that would only allow modifications to a component when that component is in a "DRAFT” or "CHECKED” state.
- the ML system may also impose business rules based on established roles of the user of the system. For example, certain users may not have the appropriate authority to move a component from a "CHECKED” state to an "APPROVED” state. By enforcing the appropriate rules, the ML system can ensure that only those components that have been reviewed by the appropriate users may be included in a particular dossier.
- FIG. 6 Also illustrated in Figure 6 is the use of a component state to impact how an approved component is used.
- components that have been "APPROVED” may be in any one of “LIVE,” “LIVE RESTRICTED,” or “FROZEN” states.
- LIVE LIVE
- LIVE RESTRICTED LIVE RESTRICTED
- FROZEN FROZEN
- Figure 7 shows an object life cycle for a data package object in one embodiment of the present invention.
- a data package object may be in a "WORKING" or "COMPLETE” state.
- business rules may be defined so that the ML system may enforce which data package objects get included in a particular dossier, as well as defining the rales of which users may change the state of a particular data package from "WORKING" to "COMPLETE.”
- a business rule may be defined through which the ML system will prevent the modification of the structure (i.e. which components it contains) of a data package where that data package is in a
- FIG 8 shows a life cycle diagram for a dossier in one embodiment of the present invention. As shown in Figure 8, a dossier may be in any one of the "WORKING,"
- Figure 9 illustrates the relationship between components, data packages, and dossiers in one embodiment of the present invention.
- DOSSIER D may include “COMPONENT A,” “COMPONENT E,” and “DATA PACKAGE 1.”
- DATA PACKAGE 1 may be made up of “COMPONENT B,” “COMPONENT C,” and “COMPONENT D.”
- DATA PACKAGE 1 By including “DATA PACKAGE 1” in “DOSSIER D,” it was unnecessary to individually include “COMPONENT B,” “COMPONENT C,” and “COMPONENT D.” Having the data package groupings of components facilitates the creation of dossiers that typically include many common components.
- DOSSIER A may be created by simply including the same five data packages that were used to create “DOSSIER A.”
- DOSSIER A may also contain a new component which can be simply added to complete the new dossier.
- the ability to create dossiers from reusable data packages, as compared to thousands of reusable components can not only improve the efficiency of creating dossiers, but also improve the quality by reusing groups of approved and up-to-date components.
- Figure 12 shows a process through which new dossiers are created using the present invention.
- the process begins at step S10 where it is determined whether new content is required to create the dossier. If new content is required, the process proceeds to step S 11 where reusable document components are created. After the new content has been created in new document components, the process proceeds to step S12 where it is determined if new reusable data packages are to be created. If it is determined that the new content should be grouped into new data packages to facilitate reuse, or if the new content should be grouped into existing data packages, the process proceeds to step S13 where data packages are created from logical groups of components.
- the creation of reusable data packages at step S13 may involve the creation of new data packages, or as discussed above, involve adding new content to existing reusable data packages.
- step S12 If it is determined at step S12 that new data packages are not required, or after the grouping performed at step S13, the process proceeds to step S14 where a new dossier is created from reusable data packages and reusable components. Similarly, if it is determined at step S10 that new content is not required, the process proceeds directly to step S14 where a new dossier can be created solely from existing data packages and components.
- Figure 13 shows a process through which the impact of an error identified in a component may be assessed.
- the process begins at step S20 where an error is identified in a component. Once an error has been identified, the process proceeds to step S21 where it is determined whether the component is contained in any reusable data packages. If it is determined that the component is contained in reusable data packages, the process proceeds to step S22 where it is determined which packages contain the defective component. The process then proceeds to step S23 where it is determined which dossiers include the reusable data packages that contain the defective component.
- step S21 If it is determined at step S21 that the defective component was not contained in any reusable data packages, or after determining which dossiers include data packages containing the defective component at step S23, the process proceeds to step S24 where it is determined which dossiers directly include the defective component. Once it has been determined which dossiers include, either directly or as a member of a reusable data package, a defective component, the process proceeds to step S25 where the impact is assessed.
- an affected document component may be moved from a ALIVE ⁇ state back to a ADRAFT ⁇ state, as shown in Figure 6, by a user having the appropriate role.
- the ML system facilitates a quick and controlled response to necessary changes (e.g., due to changes in regulations, or dangers that have been discovered) that require updates to published dossiers.
- the present invention thus also includes a computer-based product which may be hosted on a storage medium and include instructions that can be used to program a computer to perform a process in accordance with the present invention.
- the storage medium can include, but is not limited to, any type of disk including floppy disk, optical disks, CD ROMs, magneto-optical disks, ROMs, RAMs, EPROMs, EEPROMs, flash-memory, magnetic or optical cards or any type of media suitable for storing electronic instructions.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2001278575A AU2001278575A1 (en) | 2000-07-28 | 2001-07-30 | Document management and publication using reusable packages and components |
EP01956651A EP1305737A2 (en) | 2000-07-28 | 2001-07-30 | Document management and publication using reusable packages and components |
HK03106797.9A HK1056235A1 (en) | 2000-07-28 | 2003-09-22 | Document management and publication using reusable packages and components |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US62779800A | 2000-07-28 | 2000-07-28 | |
US09/627,798 | 2000-07-28 |
Publications (2)
Publication Number | Publication Date |
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WO2002010970A2 true WO2002010970A2 (en) | 2002-02-07 |
WO2002010970A3 WO2002010970A3 (en) | 2002-08-01 |
Family
ID=24516169
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2001/003395 WO2002010970A2 (en) | 2000-07-28 | 2001-07-30 | Document management and publication using reusable packages and components |
Country Status (5)
Country | Link |
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US (1) | US20040216048A1 (en) |
EP (1) | EP1305737A2 (en) |
AU (1) | AU2001278575A1 (en) |
HK (1) | HK1056235A1 (en) |
WO (1) | WO2002010970A2 (en) |
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EP1235161A2 (en) * | 2001-02-26 | 2002-08-28 | Xerox Corporation | Electronic document management system |
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US7391529B2 (en) * | 2003-01-15 | 2008-06-24 | Xerox Corporation | Apparatus and method for managing and using reusable document components during the process of dynamic document construction |
US9098475B2 (en) * | 2003-08-20 | 2015-08-04 | Xerox Corporation | Apparatus and method for generating reusable composite components during dynamic document construction |
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US7440132B2 (en) * | 2004-05-03 | 2008-10-21 | Microsoft Corporation | Systems and methods for handling a file with complex elements |
US7617450B2 (en) | 2004-09-30 | 2009-11-10 | Microsoft Corporation | Method, system, and computer-readable medium for creating, inserting, and reusing document parts in an electronic document |
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US7752632B2 (en) | 2004-12-21 | 2010-07-06 | Microsoft Corporation | Method and system for exposing nested data in a computer-generated document in a transparent manner |
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US8521736B2 (en) * | 2005-10-26 | 2013-08-27 | Dassault Systemes Enovia Corp. | Managing hierarchies of components |
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US8441668B2 (en) * | 2009-04-08 | 2013-05-14 | Palo Alto Research Center Incorporated | Permanence estimation and policy enforcement for transient printing |
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US8301722B2 (en) * | 2009-07-29 | 2012-10-30 | Hewlett-Packard Development Company, L.P. | Associating version information with a component document of a modular document |
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2001
- 2001-07-30 AU AU2001278575A patent/AU2001278575A1/en not_active Abandoned
- 2001-07-30 WO PCT/GB2001/003395 patent/WO2002010970A2/en active Application Filing
- 2001-07-30 EP EP01956651A patent/EP1305737A2/en not_active Withdrawn
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2003
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2004
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Also Published As
Publication number | Publication date |
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HK1056235A1 (en) | 2004-02-06 |
AU2001278575A1 (en) | 2002-02-13 |
EP1305737A2 (en) | 2003-05-02 |
US20040216048A1 (en) | 2004-10-28 |
WO2002010970A3 (en) | 2002-08-01 |
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