IBM Solution for Compliance in a Regulated Environment V6.1 addresses compliance and regulated document management requirements across multiple industries and applications

IBM United States Software Announcement 209-073
March 24, 2009

 
 ENUS209-073.PDF (100KB)

Table of contents   Document options  
At a glance At a glance Publications Publications
Overview Overview Technical information Technical information
Key prerequisites Key prerequisites Software Services Software Services
Planned availability dates Planned availability dates Ordering information Ordering information
Description Description Terms and conditions Terms and conditions
Program number Program number Prices Prices
Offering Information Offering Information Order now Order now
 
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At a glance
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To order, contact your IBM® representative, an IBM Business Partner, or the Americas Call Centers at: 800-IBM-CALL

Reference:

Solution for Compliance in Regulated Environment:  YE001

 
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Overview
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IBM Solution for Compliance in a Regulated Environment (IBM SCORE) V6.1 adds:

  • Support for latest Electronic Common Technical Document (eCTD) regulatory submission specifications in the European Union (EU 1.3). With these additions, IBM SCORE now supports all current regulatory submission specifications for the United States, Canada, and European Union. Additional enhancements made based on customer eCTD submissions and usage.
  • Ability to create dynamic folder views providing increased visibility to content.
  • Support for copying simple documents.
  • Support for document review cycles including annotations support for annotating documents using Adobe® reader.
  • Enhanced flexibility to configure and display search results.
  • User interface enhancements including actionable icons and better support for displaying multi-value attributes.
  • Upgrade of IBM SCORE component stack provides streamlined installation and enhancements in performance and scalability.

 
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Key prerequisites
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Refer to the Technical information section for details.


 
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Planned availability dates
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March 27, 2009: Electronic software delivery

April 17, 2009: Media and documentation


 
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Description
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IBM Solution for Compliance in a Regulated Environment (SCORE) V6.1 provides integrated document lifecycle management and Electronic Common Technical Document (eCTD) lifecycle management, enabling submission preparation to begin earlier than with traditional systems. This can help significantly reduce 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 helps dramatically reduce the effort and time needed to assemble an eCTD because you can suggest 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 support regulatory compliance efforts.

IBM SCORE V6.1 allows cross references to be added earlier in the process, from document creation, review, and assembly, and they are maintained as a document goes through multiple versions. This can help dramatically reduce the time and effort needed to maintain cross references, and eliminate the rush to add large numbers of cross references during the final assembly of a submission. IBM SCORE can also improve accuracy, 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. It provides service oriented architecture (SOA) support by including 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 manufacturers, contract research organizations, and contract manufacturing organizations, IBM SCORE provides a foundation to support efforts to comply with regulations from the FDA such as 21CFR11 and GxPs.

IBM SCORE is for 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, it provides a solution for document management needs across a variety of industries and departments.

IBM SCORE is offered at an attractive, Authorized User price. You may currently suffer from an overly complex buying experience where you must buy from multiple software vendors with different pricing models. IBM SCORE is designed to offer the software functionality you want in a single, 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.

Note: Although IBM SCORE enables organizations to address compliance and regulated document management requirements, it is your responsibility to comply with regulatory agencies' regulations and directives.

Section 508 of the U.S. Rehabilitation Act

Solution for Compliance in Regulated Environment is capable as of April 17, 2009 , 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 Voluntary Product Accessibility Template (VPAT), containing details on the products accessibility compliance, can be requested on the following Web site

http://www.ibm.com/able/product_accessibility/index.html

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.


 
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Program number
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Program    VRM                          Program name
number
 
5724-K83   6.1.0                        IBM Solution for
                                        Compliance in a Regulated
                                        Environment

 
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Offering Information
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Product information is available via the Offering Information Web site

http://www.ibm.com/common/ssi

Also, visit the Passport Advantage® Web site

http://www.ibm.com/software/passportadvantage

 
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Publications
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No hardcopy publications are shipped with this product.

The IBM Publications Center

http://www.ibm.com/shop/publications/order

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
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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 as defined in the packaging section 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 with either IBM Content Manager or Documentum Content Server as the repository but not both at the same time.

The program's specifications and specified operating environment information may be found in documentation accompanying the program, if available, such as a README file, or other information published by IBM, such as an announcement letter. Documentation and other program content may be supplied only in the English language.

Planning information

Packaging

IBM SCORE V6.1 now uses the following components and includes them in the IBM SCORE package for usage with IBM SCORE:

  • IBM Content Manager V8.4.1
  • IBM DB2® Enterprise Server Edition V9.1
  • IBM Tivoli® Directory Server V6.1
  • IBM WebSphere® Application Server Network Deployment V6.1
  • IBM WebSphere Portal Server V6.1
  • IBM WebSphere Process Server V6.1.2

Security, auditability, and control

Solution for Compliance in Regulated Environmen 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
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IBM Software 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. In addition, we extend our IBM Software Services reach through IBM Business Partners to provide an extensive portfolio of capabilities. Together, we provide the global reach, intellectual capital, industry insight, and technology leadership to support a wide range of critical business needs.


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

Product information

Licensed function title             Product group   Product
                                                    category
 
IBM Solution for Compliance in a    Content         Solution for
Regulated Environment               Manager         Compliance in
                                                    a Regulated
                                                    Environment
Program name                          PID        Charge unit
                                      number     description
 
IBM Solution for Compliance in a      5724-K83   Authorized
Regulated Environment                            Users

Charge metrics definitions

Authorized User

IBM SCORE is sold per Authorized User in minimum groups of 50.

An Authorized User entitlement must be obtained for each individual user, with a specific identity, accessing the program in any manner. Each Authorized User entitlement is attributable to one and only one unique individual specified user, either within or outside your enterprise. An Authorized User entitlement is required for each specifically identified individual user who accesses the program or any component, application, feature, function, or capability thereof, either directly or indirectly, through any means on behalf of the user. Authorized Users require entitlements for accessing content managed within, or distributed from, the program. Each Authorized User entitlement entitles one unique individual user to establish one or more connections to any number of program instances across any of the supported platforms. An Authorized User entitlement 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 entitlement has been obtained for each unique individual user.

Passport Advantage program licenses

Solution for Compliance in Regulated Environment

Part description                                         Part
                                                         number
 
IBM Solution for Compliance in a Regulated Environment
Solution for Compliance in Reg Environmt Auth Us Annual  E01QELL
 SW S&S Rnwl
Solution for Compliance in Reg Environmt Auth Us Lic +   D54VVLL
 SW S&S 12 Mo
Solution for Compliance in Reg Environmt Auth Us SW S&S  D54VWLL
 Reinstate 12 Mo

Passport Advantage supply

Program name/description                                 Part
                                                         number
 
IBM SCORE V6.1.0
IBM Solution for Compliance in a Regulated Environment   BF03XEN
 V6.1 MP EN

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 V6.1.0

Entitled maintenance        Media packs description     Part
offerings description                                   number
 
Solution for Compliance in  IBM Solution for            BF03XEN
a Regulated Environment     Compliance in a Regulated
Auth Usr                    Environment V6.1 MP EN

 
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Terms and conditions
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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 document and Proof of Entitlement (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 numbers
Program name                              Program    Form number
                                          number
 
Solution for Compliance in Regulated      5724-K83   L-GFUR-7K3NN6
Environmen

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

http://www.ibm.com/software/sla/sladb.nsf
Limited warranty applies

Yes

Money-back guarantee

If for any reason you are dissatisfied with the program and you are the original licensee, you may obtain a refund of the amount you paid for it, if within 30 days of your invoice date you return the program and its PoE to the party from whom you obtained it. If you downloaded the program, you may contact the party from whom you acquired it for instructions on how to obtain the refund.

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

Authorization for use on home/portable computer

The program may be stored on the primary machine and another machine, provided that the program is not in active use on both machines at the same time. You may not copy and use this program on another computer without paying additional license fees.

Solution for Compliance in Regulated Environment: No
International Passport Agreement
Volume orders (IVO)

No

Passport Advantage applies

Yes, and through the Passport Advantage Web site at

http://www.ibm.com/software/passportadvantage

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

Other terms
IBM Operational Support Services - SoftwareXcel

No

System i Software Maintenance applies

No

Educational allowance available

Not applicable.


 
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Prices
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For additional information and current prices, contact your local IBM representative.

Passport Advantage

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

http://www.ibm.com/software/passportadvantage

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.

https://www.ibm.com/software/howtobuy/passportadvantage/paoreseller

 
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Order now
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For more information, contact the Americas Call Centers.

Phone: 800-IBM-CALL
Fax: 800-2IBM-FAX
For IBM representative: callserv@ca.ibm.com
Mail:
IBM Teleweb Customer Support
ibm.com® Sales Execution Center, Americas North
3500 Steeles Ave. East, Tower 3/4
Markham, Ontario
Canada
L3R 2Z1
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

IBM, Passport Advantage, DB2, Tivoli, WebSphere and ibm.com are registered trademarks of IBM Corporation in the United States, other countries, or both.

Adobe is a registered trademark of Adobe Systems Incorporated in the United States, and/or other countries.

Microsoft is a registered trademark of Microsoft Corporation in the United States, other countries, or both.

Other company, product, and service names may be trademarks or service marks of others.

Terms of use

IBM products and services which are announced and available in your country can be ordered under the applicable standard agreements, terms, conditions, and prices in effect at the time. IBM reserves the right to modify or withdraw this announcement at any time without notice. This announcement is provided for your information only. Additional terms of use are located at:

http://www.ibm.com/legal/us/en/

For the most current information regarding IBM products, consult your IBM representative or reseller, or visit the IBM worldwide contacts page

http://www.ibm.com/planetwide/us/

 

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