IBM Solution for Compliance in a Regulated Environment — A management solution for your health care or life sciences organization

IBM United States Software Announcement 205-157
June 28, 2005

 

 ENUS205-157.PDF (41KB)

Table of contents   Document options  
TOC link At a glance TOC link Publications
TOC link Overview TOC link Technical information
TOC link Key prerequisites TOC link Ordering information
TOC link Planned availability dates TOC link Terms and conditions
TOC link Description TOC link Prices
TOC link Offering information TOC link Order now
 
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At a glance

IBM Solution for Compliance in a Regulated Environment (SCORE) offers the following benefits:

  • Next generation IBM regulatory compliance solutions for Life Sciences
  • Core document and regulatory process management function
  • Application integration capability
  • Business process management function
  • Ease of collaboration

For ordering, contact:

Your IBM representative or IBM Americas Call Centers at 800-IBM-CALL (Reference: YE001).
 
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Overview

IBM Solution for Compliance in a Regulated Environment (SCORE) is the next generation of the IBM regulatory compliance solutions for health care and life sciences organizations. IBM SCORE is a regulatory management solution that provides core document management function, application integration, business process management and collaboration.

IBM SCORE delivers:

  • A highly configurable solution built on open standards with proven technologies able to rapidly adapt to changing regulatory requirements
  • An integrated solution that moves beyond content-centric workflows to business process management
  • A role-based portal interface that ensures the right information is presented to the right people
  • Business integration layer and component-based architecture that supports integration with other business critical information systems
  • Document Management features that enable compliance with GXP and 21CFR11 requirements

 
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Key prerequisites

Refer to the Technical information section for details.
 
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Planned availability dates
  • July 29, 2005: Electronic software delivery
  • August 26, 2005: Media and documentation

 
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Description

IBM SCORE is the next generation of the IBM regulatory compliance solutions for Life Sciences. IBM SCORE is a regulatory process management solution that provides core document management functionality, application integration and business process management.

IBM SCORE allows compliance with regulations such as GxP and 21CFR11 for research and development (R&D), manufacturing, and sales and marketing. IBM SCORE streamlines business process management, collaboration and application integration, storing content in DB2® Content Manager or other content repositories. IBM SCORE enables technology solutions such as report-level publishing, and portal-based marketing information systems that allow organizations to meet the challenges of your business environment.

IBM SCORE uses business process management technology and methodology to allow seamless integration with business applications and operational processes. By integrating with operational systems, IBM SCORE makes eSubmissions, rolling submissions, and electronic batch records possible. Unlike existing document management systems, IBM SCORE allows for the easy connection and movement of information through regulated processes.

IBM SCORE is a bundled software solution which includes code integrating business process management technology, content management and portal-based user interface from IBM. IBM SCORE provides benefits in the following business segments:

  • R&D — Faster time to market
    • Shorten development cycle of submission documentation
    • Reduce the complexity of documentation assembly
    • Allow clinical records to be deposited directly into document management system
  • Manufacturing — Reduce regulatory risk
    • Access up-to-date manufacturing documentation (for example, SOPs, Specs)
    • Rapidly permeate changes to documentation with appropriate controls throughout the organization
  • Sales and Marketing — Shorter time to peak sales
    • Faster marketing and promotional materials development and approval cycle
    • Faster sales and marketing materials available to a broader base of sales teams

IBM SCORE functional capabilities

  • Integrated Lifecycle, Workflow and Version Management
  • Virtual Document Support
  • Collaboration Support
  • Document/Record and Submissions Lifecycle Management
  • Integrated Change Control
  • Report Level Publishing
  • Fine grained, roles based security
  • Compliant logging and auditing
  • Integrated association of documents and data
  • 21 CFR Part 11 Support through Audit Trails and Electronic Signatures

IBM SCORE provides lifecycle management for the entire document process. Features of the document lifecycle management function include:

  • Document Auto-Numbering
  • Document Versioning
  • Role-based Security Model 
  • Controlled and Reference Copy Printing
  • Integrated Change Control
  • Periodic Review
  • Make Obsolete Process
  • Controlled Import
  • Document Referencing

Workflow can occur at all structural levels including Document, Compound Documents (for example, Clinical Study Reports), Submission and Report Structures. IBM SCORE workflow goes beyond content-centric workflow to support business process management.

IBM SCORE provides complete XML-based configuration management including rapid and repeatable configurations, implementation of configuration design, replication of configuration between environments and auditing of configuration.

The IBM SCORE solution includes the following components:

  • IBM SCORE software
  • The following components are limited to use with the IBM SCORE solution only:
    • DB2 Content Manager Enterprise Edition-provides imaging, and content integration to help you meet regulatory compliance requirements and collaborate with greater productivity.
    • WebSphere® Portal Enable-delivers a single, point of personalized interaction with applications, content, processes and people for a unified user experience.
    • WebSphere Business Integration Server Foundation- provides business process management and application integration.
    • WebSphere Application Server Express-lets you deploy a core operating environment for a reliable foundation capable of high volume, security-rich transactions and Web services.
    • WebSphere Studio Application Developer — Integration Edition
  • IBM eServer® and TotalStorage® systems-leverage application flexibility, solution choice and innovative technology for extreme performance, outstanding scalability, reliability and security-rich features.
  • Integration and implementation services

IBM SCORE is available initially in English language only. Additional languages will be available in fourth quarter, 2005.

Section 508 of the U.S. Rehabilitation Act

IBM Solution for Compliance in a Regulated Envi is capable as of August 26, 2005, when used in accordance with IBM's associated documentation, of satisfying the applicable requirements of Section 508 of the Rehabilitation Act, provided that any assistive technology used with the product properly interoperates with it.

Trademarks

 
DB2, WebSphere, eServer, and TotalStorage are registered trademarks of International Business Machines Corporation in the United States or other countries or both.
 
Other company, product, and service names may be trademarks or service marks of others.

 
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Offering information

Product information is available via the Offering information Web site

Also, visit the Passport Advantage® Web site


 
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Publications

No publications are shipped with this product.

The IBM Publications Center

The Publications Center is a worldwide central repository for IBM product publications and marketing material with a catalog of 70,000 items. Extensive search facilities are provided. Payment options for orders are via credit card (in the U.S.) or customer number for 50 countries. A large number of publications are available online in various file formats, and they can all be downloaded by all countries free of charge.

The IBM Publications Notification System (PNS)

PNS enables subscribers to set up profiles of interest by order number/product number. PNS subscribers automatically receive e-mail notifications of all new publications defined in their profiles. These may then be ordered/downloaded from the Publications Center.

The PNS site is available in English and Canadian French.
 
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Technical information

Hardware requirements

The exact configuration you need to support your environment with satisfactory response time will vary depending on the size of the objects you are working with. Individual display response times vary depending on workstation speed, memory, size of objects, and network and server workload. Minimum recommended configurations listed below need to be evaluated and adjusted according to your unique requirements. Disk space recommendations are for the product installation and working space only. The actual hard disk space required varies, depending upon your installation. IBM SCORE can be installed either with DB2® Content Manager or Documentum Content Server as the repository but not both at the same time.

Minimum recommended hardware for IBM SCORE on Windows™ platforms

All of the components used by IBM SCORE are supported on Microsoft™ Windows platforms. The following section provides minimum recommended hardware requirements for the IBM software logical components.

Common Logical Components

WebSphere® Portal Server

  • 2 CPU — 2.4 GHz Pentium™ or 2.0 GHz AMD
  • 4 GB Physical Memory
  • 30 GB Free Disk Space

Business Process Management Server

  • 2 CPU — 2.4 GHz Pentium or 2.0 GHz AMD
  • 4 GB Physical Memory
  • 30 GB Free Disk Space

Overlay Rendering Server

  • Refer to your IBM services consultant, IBM SCORE documentation, and the third party vendor for current hardware requirements.

Controlled Print Server

  • 1 CPU — 2.4 GHz Pentium or 2.0 GHz AMD
  • 1 GB Physical Memory
  • 15 GB Free Disk Space

LDAP Server is required

  • 1 CPU — 2.4 GHz Pentium or 2.0 GHz AMD
  • 2 GB Physical Memory
  • 20 GB Free Disk Space

DB2 Content Manager Logical Components

DB2 Content Manager Server

  • 2 CPU — 2.4 GHz Pentium or 2.0 GHz AMD
  • 4 GB Physical Memory
  • 120 GB Free Disk Space

DB2 Universal Database® Server

  • 2 CPU — 2.4 GHz Pentium or 2.0 GHz AMD
  • 4 GB Physical Memory
  • 120 GB Free Disk Space

Adobe Elements Server

  • Refer to your IBM services consultant, IBM SCORE documentation, and the third party vendor for current hardware requirements.

Documentum Logical Components

  • Refer to your IBM services consultant, IBM SCORE documentation, and the third party vendor for current hardware requirements.

Recommended hardware for IBM SCORE on AIX® platforms

Some of the common and DB2 Content Manager logical components used by IBM SCORE are supported on the AIX platform. The following section provides minimum recommended hardware requirements for the IBM software logical components.

Common Logical Components

WebSphere Portal Server

  • 2 CPU — 1.5 GHz POWER5™
  • 4 GB Physical Memory
  • 30 GB Free Disk Space

Business Process Management Server

  • 2 CPU — 1.5 GHz POWER5
  • 4 GB Physical Memory
  • 30 GB Free Disk Space

Controlled Print Server

  • 1 CPU — 1.5 GHz POWER5
  • 1 GB Physical Memory
  • 15 GB Free Disk Space

LDAP Server is required

  • 1 CPU — 1.5 GHz POWER5
  • 2 GB Physical Memory
  • 20 GB Free Disk Space

DB2 Content Manager Logical Components

DB2 Content Manager Server

  • 2 CPU — 1.5 GHz POWER5
  • 4 GB Physical Memory
  • 120 GB Free Disk Space

DB2 Universal Database Server

  • 2 CPU — 1.5 GHz POWER5
  • 4 GB Physical Memory
  • 120 GB Free Disk Space

In addition, the Documentum components used by IBM SCORE are supported on the HP-UX platform. Refer to your IBM services consultant, IBM SCORE documentation, and the third party vendor for current hardware requirements.

Software requirements

Logical components of IBM SCORE 5.1.1

IBM SCORE includes IBM software products with its packaging as stated in the Packaging section but requires certain third party (or vendor) products from Infodata, Adobe and Documentum depending on the configuration that is implemented. IBM SCORE can be installed either with DB2 Content Manager or Documentum Content Server as the repository but not both at the same time.

Portal Server

The Portal Server component provides the web-based interface to the IBM SCORE system and hosts the application that directs the other server components. This component provides the administrator functions of IBM SCORE, including specifying configuration information defining document types and templates, lifecycle states and workflows, and users and groups.

  • AIX 5.3 or Microsoft Windows 2000 Server with Service Pack 4
  • WebSphere Portal Server 5.1
  • DB2 Information Integrator for Content V8.3 components (included with IBM SCORE package) or Documentum Foundation Classes Runtime Environment 5.2.5 SP3
  • DB2 Universal Database Administration Client 8.2 or Oracle9i 9.2.0.1.0 Client with Oracle 9iR2 Patch Set 9.2.0.4.0
  • Infodata AnnoDoc 2.0 Server

Business Process Management Server

The Business Process Management Server component provides the workflow engine that manages steps within a document's lifecycle and supports the functional logic of IBM SCORE. Since the workflow engine is external to the content server, business processes that span a document's lifecycle and other applications can be managed by this component.

  • AIX 5.3 or Microsoft Windows 2000 Server with Service Pack 4
  • WebSphere Business Integration Server Foundation 5.1.1 (included with IBM SCORE package)
  • DB2 Information Integrator for Content V8.3 components (included with IBM SCORE package) or Documentum Foundation Classes Runtime Environment 5.2.5 SP™ 3
  • DB2 Universal Database Administration Client 8.2 or Oracle9i 9.2.0.1.0 Client with Oracle 9iR2 Patch Set 9.2.0.4.0

Overlay Rendering Server

The Overlay Rendering Server component adds overlays and e-signature pages to documents according to their lifecycle state.

  • Microsoft Windows 2000 Server with Service Pack 4
  • Adobe Document Server 6.0

Controlled Print Server

The Controlled Print Server component manages document printing according to permissions set for the document.

  • AIX 5.3 or Microsoft Windows 2000 Server with Service Pack 4
  • WebSphere Application Server 5.1.1 (included with IBM SCORE package)

LDAP Server

The LDAP Server component provides directory and password management services for IBM SCORE.

  • Microsoft Windows Active Directory
  • IBM Tivoli® Directory Server

Other products may also provide an LDAP server suitable for use by IBM SCORE — please consult with your IBM services contact.

DB2 Content Manager Logical Components

Servers

The DB2 Content Manager Server component provides the repository that holds the documents managed by IBM SCORE.

  • AIX 5.3 or Microsoft Windows 2000 Server with Service Pack 4 (if the DB2 Content Manager Server requires more than 4GB of physical memory Microsoft 2000 Advanced Server needs to be installed. Consult the Content Manager sizing guidelines)
  • DB2 Universal Database V8.2
  • WebSphere Application Server 5.1.1
  • DB2 Content Manager Enterprise Edition V8.3

DB2 Universal Database Server

The DB2 Universal Database Server contains databases used by WebSphere Portal, WebSphere Scheduler, WebSphere Business Process Container, and IBM SCORE.

  • AIX V5.3 or Microsoft Windows 2000 Server with Service Pack 4 (if the DB2 Content Manager Server requires more than 4 GB of physical memory Microsoft 2000 Advanced Server needs to be installed. Consult the DB2 Content Manager sizing guidelines)
  • DB2 Universal Database V8.2

Adobe Elements Server

The Adobe Elements Server is used by IBM SCORE to render documents into non-editable formats. After rendering, IBM SCORE stores the new format into the DB2 Content Manager document repository.

  • Microsoft Windows 2000 Server with Service Pack 4
  • Microsoft Office XP Standard Edition with Service Pack 3 and Excel Post-SP3 Hotfix
  • Adobe Acrobat Professional Edition 6
  • Adobe Elements Server 6.0

Documentum Logical Components

Documentum Content Server

The Documentum Content Server component provides the document repository that holds the documents managed by IBM SCORE.

  • HP-UX or Microsoft Windows 2000 Server with Service Pack 4 (if the Documentum Content Server requires more than 4 GB of physical memory Microsoft 2000 Advanced Server needs to be installed. Consult the Documentum sizing guidelines)
  • Oracle9i 9.2.0.1 Server with Oracle 9iR2 Patch Set 9.2.0.4.0
  • Documentum Content Server 5.2.5 SP 2

Documentum Content Server Administration

The Documentum Content Server Administration component provides administrative functions for the repository managed by the Documentum Content Server component.

  • AIX 5.3 or Microsoft Windows 2000 Server with Service Pack 4
  • WebSphere Application Server 5.1.1
  • Documentum Administrator 5.2.5 SP 2

Documentum Rendering Server

The Documentum Content Rendering Server (CRS) component is used to render IBM SCORE documents into PDF on Documentum based repositories.

  • Microsoft Windows 2000 Server with Service Pack 4
  • Java™ Runtime Environment 1.4.2_05 or later
  • Microsoft Office XP Standard Edition with Service Pack 3 and Excel Post-SP3 Hotfix
  • Adobe Acrobat Standard Edition 6
  • Adobe PostScript Driver
  • Documentum Content Rendition Services 5.2.5 SP3

Administrator Workstation

The Administrator Workstation component supports a user with Administrator privileges.

  • Microsoft Internet Explorer 6.0

Reviewer Workstation

The Reviewer Workstation component supports users with Reviewer privileges. This component requires local function to view rendered documents and to capture annotations that a Reviewer makes.

  • Microsoft Internet Explorer 6.0 browser
  • Adobe Acrobat (Standard or Professional) 6.0.1 or later
  • Infodata Annodoc 2.0

Client Non-Reviewer Workstation

The Non-Reviewer Workstation component supports all other users. This component requires local function to view rendered documents.

  • Microsoft Internet Explorer 6.0 browser
  • Adobe Acrobat Reader 6.0 or later

Planning information

Packaging: The following products are included with IBM Solution for Compliance in a Regulated Environment.

  • DB2 Content Manager Enterprise Edition V8.3
  • WebSphere Portal Enable V5.1
  • WebSphere Business Integration Server Foundation V5.1
  • WebSphere Application Server — Express V5.1.1
  • WebSphere Studio Application Developer Integration Edition V5.1.1
  • DB2 UDB 8.2

IBM SCORE includes IBM software products with its packaging but requires certain third party (or vendor) products from Infodata, Adobe, and Documentum depending on the configuration that is chosen for the install.

Security, auditability, and control

IBM Solution for Compliance in a Regulated Envi uses the security and auditability features of the host hardware or software.

The customer is responsible for evaluation, selection, and implementation of security features, administrative procedures, and appropriate controls in application systems and communication facilities.
 
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Ordering information

This product is only available via Passport Advantage. It is not available as shrinkwrap.

Product information

Licensed
function                  Product              Product
title                     group                category
 
IBM Solution              Content              Solution for
Compliance                Manager              Compliance in a
Regulated                                      Regulated
Environ                                        Environment

IBM SCORE is priced per Authorized User. The initial order quantity of IBM SCORE must consist of at least 50 Authorized Users. After the initial order, additional users may be ordered in any number necessary to support your specific environment.

Charge metrics definitions

Authorized User

An Authorized User authorization must be obtained for each individual user accessing the program in any manner. Each Authorized User authorization is attributable to one and only one individual user, either within or outside your enterprise. An Authorized User authorization is required for each individual user who accesses the program or any component, application, feature, function and/or capability thereof, either directly or indirectly, through any means on behalf of the user.

Users require authorization for accessing content managed within or distributed from the program server. Each Authorized User authorization entitles one individual user to establish one or more connections to any number of program servers across any of the supported platforms. An Authorized User authorization may only be reassigned for the long-term replacement of personnel. The programs may be installed on one or more computers, and accessed by multiple users, provided that an Authorized User authorization has been obtained for each individual user. Refer to the announcement letter for further clarification and examples of permitted use.

Passport Advantage program licenses

IBM Solution for Compliance in a Regulated Envi

                                    Part
Description                         number
 
IBM Solution Compliance Regulated Environ
 
IBM SCORE Authorized User(s)        D54VVLL
 License & SW Maintenance
 12 Months
IBM SCORE Authorized User(s)        E01QELL
 SW Maintenance
 Annual Renewal
IBM SCORE Authorized User(s)        D54VWLL
 SW Maintenance
 Reinstatement
 12 Months

Passport Advantage supply

                                    Part
Description                         number
 
IBM SCORE V5.1.1
 
Media Pack English US AIX 5L,       BF02SNA
 V5, Other CD-ROM
 Digital Disk --
 ISO 9660 Standard V5.1.1

Passport Advantage customer: Media pack entitlement details

Customers with active maintenance or subscription for the products listed are entitled to receive the corresponding media pack.

IBM SCORE V5.1.1

Entitled
maintenance
offerings           Media packs                Part
description         description                number
 
Solution for        IBM SCORE English U.S.     BF02SNA
Compliance in a     AIX 5L, V5, Other
Regulated           CD-ROM Digital Disk --
Environment         ISO 9660 Standard
Auth User

 
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Terms and conditions

This product is only available via Passport Advantage. It is not available as shrinkwrap.

Agreement: IBM International Program License Agreement. Proofs of Entitlement (PoE) are required for all authorized use.

Part number products only, offered outside of Passport Advantage, where applicable, are license only and do not include Software Maintenance.

License information form number: LTYOG-5HMRPF

Limited warranty applies: Yes

Money-back guarantee: If for any reason you are dissatisfied with the Program and you are the original licensee, return it within 30 days from the invoice date, to the party (either IBM or its reseller) from whom you acquired it, for a refund.

  • For programs acquired under the IBM International Passport Advantage offering, this term applies only to your first acquisition of the Program.

Copy and use on home/portable computer: No

Volume orders (IVO): No

Passport Advantage applies: Yes and through the Passport Advantage Web site at

IBM Operational Support Services — Support line: No

iSeries™ Software Maintenance applies: No
 
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Prices

Passport Advantage

For Passport Advantage information and charges, contact your IBM representative or authorized IBM Business Partner. Additional information is also available at


 
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Order now

To order, contact the Americas Call Centers or your local IBM representative.

To identify your local IBM representative, call 800-IBM-4YOU (426-4968).

 Phone:     800-IBM-CALL (426-2255)
 Fax:       800-2IBM-FAX (242-6329)
 Internet:  ibm_direct@vnet.ibm.com
 Mail:      IBM Americas Call Centers
            Dept:  IBM CALL, 11th Floor
            105 Moatfield Drive
            North York, Ontario
            Canada M3B 3R1
 
 Reference: YE001

The Americas Call Centers, our national direct marketing organization, can add your name to the mailing list for catalogs of IBM products.

Note: Shipments will begin after the planned availability date.

Trademarks

 
POWER5, SP, and iSeries are trademarks of International Business Machines Corporation in the United States or other countries or both.
 
Passport Advantage, DB2, WebSphere, DB2 Universal Database, AIX, and Tivoli are registered trademarks of International Business Machines Corporation in the United States or other countries or both.
 
Pentium is a trademark of Intel Corporation.
 
Windows and Microsoft are trademarks of Microsoft Corporation.
 
Java is a trademark of Sun Microsystems, Inc.
 
Other company, product, and service names may be trademarks or service marks of others.

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