JP2008544335A - Computer system capable of integrating software components and software applications - Google Patents

Abstract

  A computer system comprising a software application is provided. The software application comprises a host application and an integratable software component integrated with the host application for performing control in the host application. The software component is configured to control access to functions of the host application based on data provided by the user and data stored in an external database.

Description

  The present invention relates to a computer system capable of integrating a software component and a software application, and more particularly to a computer system including an integrated software component for executing control in an application, for executing control in the application. And a software application including the software component that can be integrated.

  Applicant claims the priority of European Patent Application No. 05252385.9 filed on April 15, 2005.

  Control in the context of this application means control that permits or disallows access to the functionality of the application. For example, the control may disallow access to certain functions of the application for a group of users while permitting access to similar functions for other users.

  In the United States, the Food and Drug Administration (FDA) regulates a number of products to protect the health of the people. In this regard, it may be necessary to submit documents to the FDA by electronic means to comply with federal regulations. US Federal Regulations Section 21 Chapter 11 (21 CFR Part 11) applies records in electronic form to be generated, modified, stored, retrieved, or transferred based on the record requirements set forth in the FDA regulations Federal regulations. 21 CFR Part 11 restricts access to all computer systems used to handle files, provides audit trails, and audits by public authorities to the computer systems used to handle these files. And impose certain requirements, including rules for electronic signature rules.

  A common way to set up software that conforms to FDA rules is to individually customize applications that need to comply with 21 CFR Part 11. This customization process can include setting permissions in the application, identifying users and user groups, and setting up electronic signatures. This process must be repeated for each application.

  An object of the present invention is to allow easy execution of control of software applications, for example to facilitate meeting at least some of the requirements of the 21 CFR Part 11 rules.

  According to a first aspect of the present invention, there is provided a computer system comprising a software application, the software application being integrated into a host application and the host application for performing control in the host application. Software components. The software component is configured to control access to functions of the host application based on data provided by a user and data stored in an external database.

  Integrable software components can be integrated into multiple different software applications. The use of the same integrable software component to control different applications reduces the need for new software application by reducing the need to incorporate the functionality provided by the integratable software component, for example, login and tracking capabilities. Make development easier.

  The software component that can be integrated may be a binary software component. By using binary software components, the integratable software components can be used with host applications written in a variety of different languages. The software component that can be integrated may be a COM component.

  Integrable software components can provide an interface for exchanging information with a host application. The host application can be configured to exchange information with the integratable software component via the integratable software component interface.

  The software application can be configured such that the integratable software component and the host application are installed on the computer simultaneously. Integrable software components may be included in the installer for software applications. The installer allows a selection of software component features that can be integrated to be installed with the host application during installation.

  The software component that can be integrated can be configured to provide an authentication service. The authentication service compares user data input by the user with user data stored in an external database. The integratable software component can be configured to control access to the functionality of the software application based on authentication data provided by another software application.

  Another software application may be an authentication service provided by the operating system on which the application is running. The integratable software component can be configured to control access to the software application based on biometric authentication with suitable hardware provided in the computer system.

  Integrable software components can be configured to allow management of user data. For example, a software component that can be integrated may allow management of user names and / or groups of user names. Users related to the data can be stored in an external database.

  Integrable software components can allow permissions to be set. Permissions determine the user's authority to access the functions of the software application. Integrable software components can allow permissions to be set based on groups to which one or more users can be assigned. Data about permissions can be stored in an external database.

  The integratable software component can generate a list of all users and / or associated data stored in an external database.

  The integratable software component can be configured to generate a record of changes tailored to data on the computer system. A record of changes to the data on the computer system can be stored in an external database.

  The integratable software component can be configured to generate a login history file. The login history file contains data regarding the success and failure of attempts to log in to the software application. The login history file can be stored in an external database.

  The software component that can be integrated can be configured to provide electronic signature functionality. The integratable software component can be configured to cause the software application to require the user to use an electronic signature when performing certain operations with the software application. The integratable software component can be configured to display text that describes why an electronic signature is required.

  The integratable software component can be configured to access data stored in an external database. This external database may be provided over the network, but could alternatively be provided on the user's computer. The use of an external database allows different applications to access data stored in the database (eg, username, password, group, etc.). Furthermore, the ability to import this data directly into the application can effectively reduce setup time for applications installed on a computer system that implements the present invention. The external database can be encrypted and / or checksum calculated to improve security.

  The integrated software component and the external database can be configured such that different software applications installed on the same computer system use common data in the external database. The common data may relate to, for example, a user / name, password, group, etc.

  Integrable software components and external databases can be configured such that multiple installations of applications provided on the same computer system can access the same external database. The common data can include usernames, passwords, groups, etc., and can further include data regarding permissions within the application.

  Integrable software components and / or external databases can be configured to implement 21 CFR Part 11 requirements.

  According to a second aspect of the invention, a software component is provided that can be integrated to control functions in a host application. The integratable software component is configured to control functions in the host application based on data stored in an external database.

  According to a third aspect of the present invention, there is provided a software application comprising a host application and an integratable software component integrated with the host application to perform control of the host application. The software component is configured to control access to functions of the host application based on data stored in an external database.

  Any feature described in connection with the first aspect of the invention may be a feature of the second and / or third aspect of the invention.

  Embodiments of the present invention are described below by way of example only and with reference to the accompanying drawings.

  FIG. 1 shows a computer (10, 11, 12, 13) connected to a global security component database (3) via a local area network (2) and a user name / password authentication server (4) of Windows (registered trademark). ). In the first computer (10), an application 1 that is a first application is running and is operated by a user 1 that is a first user. The application 1 is also running on the second computer (11) and is operated by the user 2 who is the second user. On the third computer (12), the application 2 as the second application is running and is operated by the user 3 as the third user. On the fourth computer (13), the application 3 as the third application is running and is operated by the user 4 as the fourth user.

  FIG. 2 shows the first computer (10) on which the application 1 operates. The application 1 includes a host application (51) and a global security component (52). The host application (51) exchanges information with the global security component (52) via the application interface (521). The global security component (52) also has an authentication interface (522), through which the global security database (3), a Windows (registered trademark) user name / password authentication server (4), and a biometric authentication device. (6) Exchanges information with the alternative certification means (7).

  In this embodiment of the invention, the global security component is provided as a COM component programmed in C ++. COM (Component Object Model) is a software architecture designed by Microsoft (registered trademark) so that binary software components can be inter-operated. The COM component is provided in binary form with an interface through which information can be exchanged with other components or applications. COM provides a standard related to interface setup so that other components or applications can interact with the component regardless of the internal structure of the component. This allows components and applications or other components to interact with each other even if the components and / or applications are not written in the same programming language.

  A global security component (52) is provided in the application 1 for the purpose of complying with 21 CFR Part 11 requirements. The 21 CFR Part 11 requirements were briefly described in the introductory part of this specification. In particular, a global security component (52) is provided in application 1 to control access to functions of the host application (51) by the user.

  The host application (51) is used with the global security component (52) and is configured to take advantage of it. In particular, the host application (51) is configured to exchange information with the global security component (52) via its interface. In the illustrated embodiment, the host application (51) and the global security component (52) are installed on the computer (10) during a single installation. The global security component (52) is included in a merge module format that permits the installer of the host application (51) to install the host application (51) and the global security component (52) simultaneously.

  One of the functions of the global security component (52) is to provide an authentication service. The authentication service allows the user to enter information such as a username and password, for example, to gain access to the functions of the host application (51). One way that a user can authenticate using the global security component (52) is via the computer (10). For example, data such as a username and password can be entered by the user when instructed. Thereafter, the global security component (52) compares the input data with the user data stored in the global security component database (3). Alternatively, the external database may be a Windows (registered trademark) user name / password authentication server (4). The advantage of using a Windows® username / password authentication server is that the user has different usernames and passwords for logging into the computer and for using software applications (application 1, application 2 and application 3). It is not necessary to memorize.

  Authentication can be provided based on data provided from the biometric authentication device (6). It is envisioned that other sources of data for authentication can be provided and these are illustrated in FIG. 2 by alternative authentication means (7).

  When the global security component database (3) is used to store data used to authenticate user details, it is important that this database is not tampered with. The database (3) shown in FIG. 2 is both encrypted and checksum calculated to improve security.

  The global security component (52) provides the following additional functions. The global security component (52) can be used to manage user names and passwords stored in the global security component database. The global security component (52) adds a username / password and modifies the username / password so that they can be approved or rejected if authenticated by the global security component (52). The user name and password can be deleted, and the function in which the user name and password are recorded can be permitted / not permitted.

  In addition, the global security component can enforce a password policy that, for example, rejects passwords that are less than a predetermined length or requests that passwords be changed periodically.

  As described above, the global security component (52) controls user access to the functions of the host application (51). The global security component (52) provides permissions to access the functions of the host application (51) based on the group. For example, a group with a user name can be given access rights to all functions of application 1. The global security component (52) also allows group management, which allows users to be added to or removed from a group, and permissions can be assigned to groups and / or individual users. to approve.

  The global security component (52) can provide a summary identifying all user information stored in the global security component database (3). In addition, the global security component (52) records a login history that records the success and failure of login attempts through the global security component (52). The login history is stored in the global security component database (3).

  In addition, a digital security function can be provided in the host application (51) by the global security component (52). For example, an electronic signature may be added to record or communicate that the user is working with the electronic signature. The global security component (52) can also be used to provide a signature point. At the signature point, the user is required to provide an electronic signature when using software applications to perform special actions, such as approving or rejecting a report. In addition, the software application can display text explaining why an electronic signature is required at that signature point.

  FIG. 1 shows various computers running various software applications. In the first computer (10) and the second computer (11), an application 1 that is the same application is running. As described above, the user name, password, and permission data are stored in the global security component database (3). The application 1 accesses the same data when running on both the first computer (10) and the second computer (11).

  Thus, if user 1 logs off from the first computer (10) and walks to the second computer (11), user 1 can log in to the second computer (11) and the first computer ( 10) As with the above, application 1 can be accessed in the same way (using the same username and password, and thus using the same permissions).

  In the third computer (12), the application 2 is running. The application 2 is also composed of a host application and a global security component (52). However, the host application is different from the host application in application 1.

  This is because application 2 uses the same global security component (52) as application 1, which has the same authentication process. Furthermore, the global security component (52) accesses the global security component database (3) over the local area network (2), and the application 2 uses the same user name and password as the application 1. However, since the host application in application 2 is different from the host application in application 1, the potential functions of application 2 are different. From this point of view, the permissions relating to the user of the first application are not used for the application 2. However, if application 1 is subsequently installed on the third computer (12), the username, password, and permission data from the global security component database are available for a new installation of application 1.

  Through the design of the global security component, the global security component (52) can be integrated into any host application that is suitably designed to utilize the global security component interfaces (521, 522). When such a software application is provided on a network with a common global security database, the application eliminates the need to set up username and password information in each application individually and stores it in the global security component database (3). Use common data.

1 shows a layout of a computer system embodying the present invention. 2 shows a structure of an application executed on a computer in the computer system shown in FIG.

Explanation of symbols

2 local area network 3 global security component database 4 Windows (registered trademark) user name / password authentication server 6 biometric authentication device 7 alternative authentication means 10 first computer 11 second computer 12 third computer 13 fourth computer 51 host application 52 Global security component 521 Application interface 522 Authentication interface

Claims (49)

A computer system comprising a software application,
The software application comprises a host application and an integratable software component integrated with the host application to perform control in the host application;
The computer component is configured to control access to functions of the host application based on data provided by a user and data stored in an external database.   The computer system of claim 1, wherein the integratable software component can be integrated into a plurality of different software applications.   The computer system according to claim 1, wherein the software component that can be integrated is a binary software component.   4. The computer system according to claim 3, wherein the integratable software component is a COM component.   5. The computer system according to claim 1, wherein the integrable software component provides an interface for exchanging information with the host application.   6. The host application according to claim 1, wherein the host application is configured to exchange information with the integrable software component via an interface of the integrable software component. The computer system according to item. The integratable software component is configured to provide an authentication service;
The computer system according to any one of claims 1 to 6, wherein the authentication service compares user data input by a user with user data stored in the external database.   The computer of claim 7, wherein the integratable software component is configured to control access to functionality of the software application based on authentication data provided by another software application. system.   9. A computer system as claimed in any preceding claim, wherein the integratable software component is configured to allow management of user data. The integratable software component is configured such that permissions can be set;
The computer system according to claim 1, wherein the permission determines a user's authority to access a function of the software application.   11. The computer system of claim 10, wherein the integratable software component is configured to be able to set permissions based on a group to which one or more users can be assigned.   12. A computer system as claimed in any preceding claim, wherein the integratable software component is configured to provide an electronic signature function.   The integratable software component is configured to cause the software application to require a user to use an electronic signature when performing certain operations with the software application. Item 13. The computer system according to Item 12.   The computer system of claim 13, wherein the integratable software component is configured to display text that describes why an electronic signature is required.   The computer system according to any one of claims 1 to 14, wherein the external database is provided over a network.   The computer system according to claim 1, wherein the external database is encrypted.   The computer system according to claim 1, wherein the external database is checksum calculated.   The integrated software component and the external database are configured such that different software applications installed on the same computer system can use common data in the external database. 18. The computer system according to any one of items 17 to 17.   The integrated software component and the external database are configured such that multiple installations of applications provided on the same computer system can access the same external database. 19. The computer system according to any one of items 18 to 18.   20. At least one of the integratable software component and the external database is configured for implementation of 21 CFR Part 11 requirements. Computer system. An integrated software component for controlling functions in a host application,
An integrable software component configured to control functions in a host application based on data stored in an external database.   The integrable software component of claim 21, wherein the integratable software component can be integrated into a plurality of different software applications.   23. Integrable software component according to claim 21 or 22, characterized in that it is a binary software component.   24. Integrable software component according to claim 23, which is a COM component.   25. Integrable software component according to any one of claims 21 to 24, characterized in that it provides an interface for exchanging information with a host application. The integratable software component is configured to provide an authentication service;
26. The integratable software component according to any one of claims 21 to 25, wherein the authentication service compares user data input by a user with user data stored in an external database.   27. The integratable software component of claim 26 configured to control access to functionality of a software application based on authentication data provided by another software application.   28. Integrable software component according to any one of claims 21 to 27, configured to allow management of user data. The integratable software component is configured such that permissions can be set;
29. Integrable software component according to any one of claims 21 to 28, wherein the permissions determine a user's authority to access functions of a software application.   30. The integratable software component of claim 29, wherein the integratable software component is configured to allow permissions to be set based on a group to which one or more users can be assigned.   31. An integratable software component according to any one of claims 21 to 30 configured to provide electronic signature functionality.   32. Integrable software according to claim 31, wherein when performing an operation using a software application, the software application is configured to require a user to use an electronic signature. component.   The integratable software component of claim 32, configured to display text that describes why an electronic signature is required.   34. Integrable software component according to any one of claims 21 to 33, configured for the implementation of 21 CFR Part 11 requirements. A software application comprising: a host application; and an integratable software component integrated with the host application to perform control in the host application,
A software application, wherein the software component is configured to control access to a function of the host application based on data stored in an external database.   36. The software application of claim 35, wherein the integrable software component can be integrated into a plurality of different software applications.   37. A software application according to claim 35 or 36, wherein the integratable software component is a binary software component.   The software application of claim 37, wherein the integratable software component is a COM component.   39. A software application as claimed in any one of claims 35 to 38, wherein the integratable software component provides an interface for exchanging information with the host application.   40. The host application according to any one of claims 35 to 39, wherein the host application is configured to interact with the integratable software component via an interface of the integratable software component. Software application as described in The integratable software component is configured to provide an authentication service;
41. A software application according to any one of claims 35 to 40, wherein the authentication service compares user data input by a user with user data stored in an external database.   The software of claim 41, wherein the integratable software component is configured to control access to functionality of the software application based on authentication data provided by another software application. application.   43. A software application according to any one of claims 35 to 42, wherein the integratable software component is configured to be allowed to manage user data. The integratable software component is configured such that permissions can be set;
44. A software application according to any one of claims 35 to 43, wherein the permission determines a user's authority to access a function of the software application.   45. The software application of claim 44, wherein the integratable software component is configured to allow permissions to be set based on a group to which one or more users can be assigned.   46. A software application as claimed in any one of claims 35 to 45, wherein the integratable software component is configured to provide electronic signature functionality.   The integratable software component is configured to cause the software application to require a user to use an electronic signature when performing certain operations with the software application. Item 47. The software application according to Item 46.   48. The software application of claim 47, wherein the integratable software component is configured to display text that describes why an electronic signature is required.   49. A software application as claimed in any one of claims 35 to 48, wherein the integratable software component is configured for implementation of 21 CFR Part 11 requirements.

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