IBM Solution for Compliance in a Regulated Environment V5.1.3 — A management solution for your health care or life sciences organization

IBM United States Software Announcement 206-301
November 21, 2006

 

 ENUS206301.PDF (28KB)

Table of contents   Document options  
TOC link At a glance TOC link Technical information
TOC link Overview TOC link Software services
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
TOC link Publications  
 
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At a glance

IBM Solution for Compliance in a Regulated Environment (IBM SCORE) V5.1.3:

  • Full document lifecycle and Electronic Common Technical Document (eCTD) lifecycle management from creation through submission
  • Compound document assembly, eCTD assembly, communications and correspondence management, registration status tracking
  • Unique cross reference tools for Microsoft Word and Adobe Acrobat allow cross references to be added during the authoring and review cycles
  • Enhanced support to run in a service oriented architecture (SOA) environment, including Web Services interfaces to ease integration with other applications

For ordering, contact:

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

IBM Solution for Compliance in a Regulated Environment (IBM SCORE) enables organizations to meet compliance and regulated document management requirements across multiple industries and applications.

IBM SCORE V5.1.3 adds:

  • Enhanced compound document assembly
  • Electronic Common Technical Document (eCTD) creation for submissions to regulatory agencies such as the Food and Drug Administration (FDA) and European Medical Evaluation Agency (EMEA)
  • Unique cross reference tools

New capabilities include:

  • Full document lifecycle and eCTD lifecycle management from creation through submission
    • Planning, tracking, and monitoring
    • Status dashboards
    • Workflow management at eCTD and node level
    • Full lifecycle audit trails
  • Compound document assembly/eCTD assembly
    • Easier to use portal interface
    • Auto-suggest feature to automate the placement of components based on document metadata, speeds assembly, reduces effort, and shortens assembly time
  • Unique cross reference tools for Microsoft™ Word and Adobe Acrobat
    • Allow cross references to be added during the authoring and review cycles, eliminating the rush to add large numbers of cross references during the final assembly of a submission.
    • Cross references are also maintained as new versions of documents are created.
    • Accuracy is improved, as users can check the cross references during the creation, review, approval, and assembly of documents and submissions.
  • Communications and correspondence management
  • Submissions planning and tracking

 
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Key prerequisites

Refer to the Technical information section for details.


 
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Planned availability dates
  • November 24, 2006: Electronic software delivery
  • December 15, 2006: Media and documentation

 
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Description

IBM SCORE enables organizations to meet compliance and regulated document management requirements across multiple industries and applications.

New features in this release focus on enhancing support of compound document assembly, regulatory submissions planning and tracking, and electronic Common Technical Document (eCTD) creation for submissions to agencies such as the FDA and EMEA.

IBM SCORE provides integrated document lifecycle management and eCTD lifecycle management, enabling submission preparation to begin earlier than with traditional systems, significantly reducing the work that must be done during the final steps in preparing a submission. The submissions management capabilities include planning, tracking, monitoring and status dashboards. Review and approval workflows are supported at the eCTD and the node level. The Auto-Suggest feature dramatically reduces the effort and time needed to assemble an eCTD by suggesting placement of documents within an eCTD based on a document's metadata. A single audit log is used to track activities from document creation through eCTD submission, helping to ensure regulatory compliance.

A unique approach to cross references allows cross references to be added earlier in the process, during document creation, review, and assembly, and they are maintained as a document goes through multiple versions. This dramatically reduces the time and effort needed to maintain cross references, and eliminates the rush to add large numbers of cross references during the final assembly of a submission. Accuracy is also improved, as users can check cross references during the creation, review, and approval phases of documents and submissions. IBM SCORE provides cross reference tools for Microsoft Word and Adobe Acrobat.

IBM SCORE also enables the tracking of communications and correspondence with regulatory agencies, and the creation, review, and approval of responses to inquires, and enhances its SOA support by including additional Web Services interfaces to ease integration with business processes and other applications such as ERP, CRM, and paper publishing applications.

For life sciences companies, such as pharmaceutical, biotech, generics manufactures, contract research organizations, and contract manufacturing organizations, IBM SCORE provides a foundation for compliance with regulations from the FDA such as 21CFR11 and GxPs.

IBM SCORE applies to regulated business processes including research and development, clinical trials, regulatory affairs and submissions, manufacturing, corrective action and preventative action, safety and adverse event reporting, packaging and labeling, marketing materials and advertising.

IBM SCORE can also be used in less regulated areas of the organization such as research and discovery, good IT practices (GITP) documentation, IP management, contracts and legal, because of IBM SCORE's extensive configuration options, thus providing a solution for all document management needs across a variety of industries and departments.

Hospitals and other healthcare providers produce countless documents, from clinical areas such as pathology and lab services, to business areas such as human resources, corporate planning, and the board room. The creation, review, approval, and release of this information has always posed a challenge in healthcare environments. Often, each department has its own method of creating, maintaining, and distributing paper records. IBM SCORE helps hospitals with the cost, time, and effort in producing and maintaining those documents, and can help ensure the use of current information, policies, and procedures throughout a hospital.

IBM SCORE is offered as at an attractive, authorized user price. Many customers currently suffer from an overly complex buying experience where they must buy from multiple software vendors with different pricing models. IBM SCORE is designed to offer the necessary software functionality in a simpler package.

Consulting, implementation, validation, and training services are available from IBM Global Business Solutions and can deliver validated, production-ready systems. IBM's experience and project accelerators speed time to value for the user community.

IBM SCORE is available initially in English only. Additional languages will be available in the first quarter of 2007.

Accessibility by people with disabilities

A U.S. Section 508 Voluntary Product Accessibility Template (VPAT) can be requested via IBM's Web site

Section 508 of the U.S. Rehabilitation Act

Solution for Compliance in Regulated Environment is capable as of December 15, 2006, 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. A U.S. Section 508 VPAT, containing details on the products accessibility compliance, can be requested at

IPLA and Subscription and Support considerations

IPLA licenses can be transferred from one machine to another within, but not limited to an enterprise. You may aggregate the capacity for all the processors the product is operated on to achieve a more economic price. This will result in a single Proof of Entitlement (PoE). It is your responsibility to manage the distribution of Value Units within the limits of the entitlement of the product license.

Subscription and Support must cover the same capacity as the product license entitlement. Subscription and Support will be available in the country in which the agreement is made.

Trademarks

 
Microsoft is a trademark of Microsoft Corporation.
 
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 hardcopy 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 20 countries. A large number of publications are available online in various file formats, and they can all be downloaded by all countries.
 
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Technical information

Specified operating environment

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. You should consult your IBM representative to determine the recommended hardware configurations and software requirements for your utilization of the IBM SCORE solution.

Software requirements

IBM SCORE includes several IBM software products but requires certain third party (or vendor) products from ISI, 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.

Security, auditability, and control

IBM SCORE 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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Software services

IBM services has the breadth, depth, and reach to manage your services needs. You can leverage the deep technical skills of our lab-based, software services team and the business consulting, project management, and infrastructure expertise of our IBM Global Services team. Also, we extend our IBM Software Services reach through IBM Business Partners to provide an unmatched portfolio of capabilities. Together, we provide the global reach, intellectual capital, industry insight, and technology leadership to support any critical business need.

To learn more about IBM software services or to contact a software services sales specialist, visit

To locate an IBM Business Partner, visit


 
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Ordering information

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

Product information

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

                                  PID            Charge unit
Program name                      number         description
 
IBM Solution for Compliance       5724-K83       Authorized
 in a Regulated Environment                       Users

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 is one and only one individual (named or unnamed) within or outside Your enterprise. A PoE must be obtained for each individual user accessing the program in any manner. A program licensed under an authorized user PoE may be installed on a single computer or server, and accessed by multiple users, provided that a PoE has been obtained for each individual user accessing the program either directly or indirectly (via a multiplexing program, device, or application server) through any means on behalf of the user.

Passport Advantage program licenses

IBM SCORE

                                                     Part
Part description                                     number
 
IBM Solution for Compliance
 in a Regulated Environment
 
IBM SCORE Authorized Users                           D54VVLL
 License & SW Maintenance 12 Months
IBM SCORE Authorized Users SW                        E01QELL
 Maintenance Annual Renewal
IBM SCORE Authorized Users SW                        D54VWLL
 Maintenance Reinstatement 12 Months

Passport Advantage supply

                                                     Part
Program name/description                             number
 
IBM SCORE V5.1.3
 
IBM Solution for Compliance in a Regulated           BF030EN
 Environment V5.1.3 MP English MP

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 V5.1.3

Entitled maintenance                                   Part
offerings description        Media packs description   number
 
Solution for Compliance in   IBM Solution for          BF030EN
 a Regulated Environment      Compliance in a Regulated
 Auth User                    Environment V5.1.3 MP
                              English MP

 
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Terms and conditions

The information provided in this announcement letter is for reference and convenience purposes only. The terms and conditions that govern any transaction with IBM are contained in the applicable contract documents such as the IBM International Program License Agreement, IBM International Passport Advantage Agreement, and the IBM Agreement for Acquisition of Software Maintenance.

Licensing: IBM International Program License Agreement including the License Information (LI) document and PoE govern your use of the program. PoEs 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

                                Program
Program name                    number         Form number
 
Solution for Compliance         5724-K83       L-MHAN-6S5M45
 in Regulated Environment

The program's LI will be available for review on the IBM Software License Agreement Web site

Limited warranty applies: Yes

Warranty: IBM warrants that when the program is used in the specified operating environment it will conform to its specifications. The warranty applies only to the unmodified portion of the program. IBM does not warrant uninterrupted or error-free operation of the program or that IBM will correct all program defects. You are responsible for the results obtained from the use of the program.

IBM provides you with access to IBM databases containing information on known program defects, defect corrections, restrictions, and bypasses at no additional charge. Consult the IBM Software Support Guide for further information at

IBM will maintain this information for at least one year after the original licensee acquires the program (warranty period).

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 Agreement, this term applies only to your first acquisition of the program.

Copy and use on home/portable computer: No

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

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

Agreement for Acquisition of Software Maintenance: The following agreement applies for maintenance and does not require customer signatures:


    IBM Agreement for Acquisition of Software Maintenance (Z125-6011)

Volume orders (IVO): No

IBM Operational Support Services — SoftwareXcel: No

iSeries™ Software Maintenance applies: No

Educational allowance available: Not applicable.
 
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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

Business Partner information

If you are an IBM Business Partner — Distributor for Workstation Software acquiring products from IBM, you may link to Passport Advantage Online for resellers where you can obtain Business Partner pricing information. An IBM ID and password are required.


 
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Order now

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

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

 Phone:      800-IBM-CALL (426-2255)
 Fax:        800-2IBM-FAX (242-6329)
 Internet:   callserv@ca.ibm.com
 Mail:       IBM Americas Call Centers
             Dept. Teleweb Customer Support, 9th 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

 
iSeries is a trademark of International Business Machines Corporation in the United States or other countries or both.
 
Passport Advantage, DB2, and PartnerWorld 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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