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Managing FDA regulatory compliancewith IBM Rational solutions

2 Managing FDA regulatory compliance with IBM Rational solutions

Executive summaryToday’s healthcare, life sciences and medical device industriesare faced with unpredictable market change, global competi-tion, and constantly evolving regulatory mandates and guide-lines. To remain viable and competitive, corporations mustbalance rapid innovation with compliance mandates that dictate safety and effectiveness. The necessity to innovate andevolve the business in order to leverage new technologies suchas biologics, advanced drug treatments or software-enabledmedical devices while maintaining compliance requires organizations to undergo significant business process anddevelopment life cycle transformations. Many in the industryhave expressed concern that the processes dictated by thebroad and evolving governmental regulations and guidelines(such as FDA, GMP, etc.) negatively impact time-to-marketand increase development time.

The United States Food and Drug Administration (FDA) regulates over $1 trillion in products including, but not limited to:

● Pharmaceuticals for human and animal use.● Biological and related products including vaccines, and bio-

logical therapeutics.● Medical devices.● Radiation emitting devices.

The FDA monitors the production, import, transport, storageand sale of these products in the United States. Compliancewith FDA regulations is a market requirement. Failure tocomply can be very costly, not only due to expensive violationsor recalls, but also due to criminal penalties and loss of marketshare for those who don’t comply with regulations.

Achieving development life cycle efficiencies and injectingmore agile development practices while maintaining compli-ance to regulations such as those dictated by the FDA is oftenreported as a foremost concern. It is our view that given high-quality development and design control processes andsufficient tools to support and automate these processes, timeto market can actually be decreased, while resulting in higherquality, and higher reliability products and services. This doc-ument gives a brief overview of the current challenges that thehealthcare industry faces and discusses how IBM® Rational®solutions can help address these challenges.

The Rational solutions for systems and software engineeringcan assist with reaching FDA compliance goals through integration, collaboration, automation and reporting. Thesolutions support the creation and management of life-cyclework products necessary to fulfill FDA regulations and guide-lines. The solutions provide a core set of best-in-class toolsand processes for systems and software engineering teams,facilitating engineering collaboration with unprecedented high level of transparency of project progress, control of arti-facts, traceability with audit trails, task management andchange control.

Lastly, the Rational solutions address the FDA identified lackof design controls as one of the major causes of device recalls by:

● Maintaining design control specifications in a central, auto-mated repository

● Providing design control specifications using customizabledocument templates

● Facilitating the design control process models, attributes and reports

● Maintaining up-to-date traceability matrices● Facilitating change impact analysis and capturing

design history● Managing compliance

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Smarter healthcareToday’s healthcare field is quickly evolving and increasinglybecoming more networked and interconnected. Whether youare developing a cutting-edge medical device, researching newdrug therapies or providing healthcare services, the commonthread is an increasing reliance on interconnected informa-tion, networks, products, and complex systems.

To meet innovation goals and bring new products to marketfaster, companies must focus on optimizing the developmentprocesses supporting and automating these efforts. As today’shealthcare providers, payers and consumers move towardselectronic records management and smarter healthcare, thiswill mean that medical devices used to implement our caremust not only communicate data to doctors, nurses and clini-cians but may also transmit data for more accurate billing andmore comprehensive patient data management. Medicaldevices are becoming more sophisticated and complex withthe greater ability to give real-time statistics to clinicians inorder to make better diagnosis and care decisions. Manydevices today record and transmit patient and device data backto physicians and device manufacturers to aid in patient care,and to help influence development of new products and fea-tures in order to repurpose or modernize existing productlines. Devices are becoming more and more customized andoffer variances that meet hospital, emergency response andfield needs. Data is being continually analyzed to make diagnosis early and to predict outcomes.

In the life sciences field, drug trials and drug therapies arebecoming customized with new research leading to new solu-tions, drugs and biological applications. Pressure to increaseoutput from clinical research and development (R&D) isexpanding as life sciences companies ward off market pressuresfrom generic drugs.

Healthcare reform will potentially impel tens of millions ofAmericans who do not currently have healthcare insuranceinto the healthcare network, driving demand for access totreatments such as drugs, biologics and increasing medicaldevice usage. The push towards electronic medical recordsand mandates such as the Health Insurance Portability andAccountability Act (HIPAA) and massive changes in electronicdata interchange and International Classification of Diseases(ICD) codes will drive modernization of core healthcare appli-cations and systems. The cost of reform and compliance willdrive technology investments to modernize legacy systems andto develop new business models.

What is the common driver to delivering smarter healthcaresuch as sophisticated devices, drugs and biologics or modernhealth maintenance networks? Software. Software is increas-ingly becoming the key factor for injecting new features, func-tions, and providing protocols for networking and buildingsystem user interfaces. All these software-driven capabilitieslead to what we call smarter healthcare—such as modern portal-based payer/provider/consumer networks, complexinformation data management systems, intelligent medicaldevices, and pioneering drug and biologics research and development. Software is the key to competitive advantage.

In the next few sections we will look at some of the regulatoryand compliance demands on the healthcare industry and lookat the corresponding challenges created by compliance drivendevelopment within the medical device, healthcare payers,healthcare service providers and life sciences industries andexplore how Rational solutions help address these challenges.

Medical device and life sciences industrychallengesMedical device manufacturers must manage complex systemrequirements and provide quality development processes tomanage portfolios of products. Medical device developers

4 Managing FDA regulatory compliance with IBM Rational solutions

must base product strategies on real data, classify risks andensure proper mitigation of hazards while controlling softwareand systems development life cycles to ensure quality throughrigorous testing. Ongoing studies of effective product develop-ment point to significant failure rates—failure to deliver ontime with the right features and functionality. Success dependson the ability to deliver faster, increase productivity andensure high quality while reducing costs in the developmentcycle. All of these challenges are compounded by the need toensure adherence to regulations and mandates.

Listed below are just a few of the challenges medical devicedevelopers face along with some of the key factors that theymust control to remain competitive and successful:

● Corporate strategy and planning: Percentage of sales dueto new products or new systems released, return on marketinvestment, strategic planning operating budget per revenue,return on total assets.

● Product/Platform strategy: Number of products per plat-form, amount of software per platform, cost for each newproduct or system, cost of modernization.

● Functional innovation: Improving time to market, increas-ing market share, achieving price premiums and return oninvestment for development.

● Prototype development and testing: Time from develop-ment to maturity, new product or system success rate, cost per engineering change, time and cost for conceptualmockups.

● Risk and hazard mitigation: Meet mandates for classifica-tion and management of risks and hazards (Failure Modesand Effects Analysis [FMEA]).

● Legal and regulatory compliance: FDA, number ofnotices of violations from regulatory agencies, dollar value of potential legal liabilities, patents, corrective andpreventive actions (CAPA)

Life sciences companies face the need for increased opera-tional efficiency and cost containment as payers worldwideactively push-back on new and existing drug pricing. Newinnovations are always necessary to retain market share: discovery research is an important area with considerablygrowing risk, compliance and change control requirements.There is a need for a reliable infrastructure for reducing thepossibility and impact of clinical data security and compliancevulnerabilities. Increasingly, scientists who are testing new discoveries are using outdated and inefficient tools and techniques at the same time that research and developmenthas become more expensive. The result is a slow and costlyprocess. Drug manufactures must support collaborative envi-ronments, automate the change control process and moreeffectively capture and communicate data to encouragequicker development.

Listed below are just a few of the challenges life sciences com-panies face along with some of the key factors that they mustcontrol to remain competitive and successful:

● Product portfolio management: Make the right R&Dinvestments, return on investment, strategic product plan-ning, percentage of sales due to new products, impact ofgenerics and competition on product lines.

● Security: Ensure security of data and reliable managementof the infrastructure; reduce the possibility and impact ofsecurity vulnerabilities.

● New scientific initiatives: Targeted treatments and tailoredmedicine challenge traditional push oriented developmentmodel.

● Operational excellence: Maintain requirements for manu-facturing execution process, meet product, regulatory andproductivity requirements.

● Legal and regulatory compliance: CGMP, GAMP(Current Good Automated Manufacturing Practice).

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● Verification and validation (V&V): Validate tools andprocesses used in development and manufacturing of prod-ucts, verify processes.

● Change control: Manage change, impact analysis of changeduring development or manufacturing processes.

● Cost pressures: Control costs of infrastructure for com-mercial and clinical development.

Regulations impacting the medical device industryThe medical device industry is faced with ever increasing reg-ulation and oversight of the design control process due toincreased focus on device recalls and unintended consequencesof improper use. In the FDA’s own words, “Since 1984, FDAhas identified lack of design controls as one of the majorcauses of device recalls. The intrinsic quality of devices,including their safety and effectiveness is established duringthe design phase”1

In response to device safety concerns the FDA created theQuality Systems Regulations (QSR CFR 21 part 820) toensure that products meet requirements and specifications andthat current good manufacturing practices are followed in thedevelopment of devices.

Some of the key parts of the QSR that are of concern todevice development organizations are:

● Strict design control measures.● Use of tools to improve the development process.● Separate definition and traceability of user requirements to

design input.● Separation of validation (user and patient needs are met)

from verification procedures and record keeping (specifiedrequirements are met).

● Software validation requirements that apply to software usedas components in medical devices, to software that is itself amedical device, and to software used in production of thedevice or in implementation of the device manufacturer’squality system.

The FDA regulation provides a framework but leaves it up todevice developers to implement quality development proce-dures. It is the responsibility of manufacturers to establishrequirements for each type or family of devices that will resultin products that are safe and effective, and to establish meth-ods and procedures to design, produce, and distribute devicesthat meet the quality system requirements. Lack of designcontrols is one of the major reasons for device recalls and violation notices resulting from FDA audits. Adherence to adevelopment process that defines requirements, indentifiesrisk, manages change and facilitates and supports simulationand test well before implementation lowers development riskand costs and reduces time to market. Product expenditureskyrockets when deficiencies are discovered late in the devel-opment life cycle. Following a design control process that isrepeatable, scalable, and automated can provide better projectvisibility and predictability, lowering overall costs, reducingproduct development time, and helps to navigate regulatoryacceptance into the market.

However, developers often view compliance to these designcontrol standards as overhead, interfering with their designwork. The regulatory and quality populace is ultimatelyresponsible for design control compliance, but they depend onhardware, software and mechanical designers and developersto do the actual work. Developers often respond to the regula-tory professionals with “What do you want, a product or documentation?” However, medical device manufacturesrequire confirmation that user needs are met by design inputsand that the design elements that are essential to the properfunctioning of the device are identified, recorded, and tracked,in order to survive inspections and bring safe products to mar-ket. Companies must also establish reasonable design controlprocesses and ensure that risk analysis is performed, changesto requirements and development artifacts are controlled anddesign history files are maintained. Management and proper

6 Managing FDA regulatory compliance with IBM Rational solutions

tracing of requirements from the original design and develop-ment phase through the verification and validation phasealong with an accompanying risk management plan is crucialto remaining viable in the medical device market.

Automation of the capture, recording and traceability betweenthese items not only cuts the time spent focused on regulatorycompliance but can speed development time. Adherence to aprocess that identifies requirements before implementation andthen controls and manages requirements and requirementchange throughout the design process is more efficient andrequires fewer design iterations. When the requirements areidentified, progress metrics and projection of completion datesare more objective and quantitative. Even when new require-ments are identified mid-design or mid-implementation, theimpact on the overall schedule is more quantitatively pre-dictable when the requirements are properly captured anddependencies between requirements are maintained. Clientsare often skeptical that following such a process can reducetime to market, but in addition to the efficiencies noted above,a good design control process followed by change and designreviews supported by change management allows problems tobe identified earlier in the process while they are smaller, sim-pler, faster, and cheaper to fix.

Regulations impacting the life sciences industriesThe task of the FDA’s Center for Drug Evaluation andResearch (CDER) and Center for Biologics Evaluation andResearch (CBER) is to ensure drug products are safe andeffective. CDER and CBER regulate new drug and biologicapplication development, perform quality testing, evaluatemanufacturing processes and enforce post-market surveillancefor safety and efficacy.

Some of the key parts of the regulations that are of concern tolife sciences organizations comprise:

● Overseeing new drug development● Review of drug and biologic product applications

● Managing safety, performance and promotion of marketeddrugs

● Monitor drug quality and efficacy

While the FDA does not do any drug testing, the agency doesreview results of non-clinical and clinical studies submitted bya manufacturer and inspects the manufacturer of the products.The vast majority of time invested in drug development is inthe pre-clinical research and the clinical studies phases. Whileless time is invested in FDA submission and review processes,process concerns, errors or problems in the research, datarecording or execution systems can lead to very costly rework or missed market opportunities. Very few candidatecompounds have the desired effect leading to drug productsthat can actually make it to market. Therefore, management,traceability and security of information related to drug devel-opment is of paramount concern, especially due to the ongo-ing involvement of the FDA regulators throughout the drugdevelopment and review process.

How Rational solutions can helpIBM Rational can help with implementing an effective designcontrol process and a standard quality systems process sup-ported by best-in-class tooling to allow an organization todevelop a corporate standard process which will provide effi-ciencies of scale. Developers can know what to expect and canincorporate design control processes in line with FDA qualitysystems and Good Manufacturing Practice (GMP) guidelines.The Rational solutions for systems and software engineeringsupports collaborative tasks and linking of the life-cycle workproducts. Compliance can be made simpler with automatedcapture of design history, life cycle traceability and qualitymanagement processes required to manage compliance to regulations.

Demonstrating compliance means control and documentationof the typical development tasks such as requirements gather-ing, analysis, system design, detailed design, verification andvalidation, risk analysis, project management and reporting.

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The IBM Rational software and systems delivery solutionsoffer visibility, control and automation. It is an open, proven,complete and modular solution comprising a comprehensiveset of tools and best practices. IBM Rational solutions offer allthe tools that teams need to successfully define requirements,model, build, test, and deploy products.

Without integrations across the systems delivery life cycle,systems and software teams are left to operate in silos. Whensilos form, product delivery effectiveness suffers. In order todeliver smarter products that respond to changing marketneeds, it is necessary to allow systems and software engineer-ing teams to perform efficiently and to collaboratively manageall the life-cycle work products. The Rational solutions forsystems and software engineering provide complete life-cyclemanagement—an integrated and collaborative environment

for requirements analysis; architecture management; andwork, change and configuration management for teams of sys-tems engineers. The Rational solutions include:

● IBM Rational Focal Point™ software for product andportfolio management

● IBM Rational DOORS® software for requirements man-agement, traceability, and impact analysis capabilities

● IBM Rational Rhapsody® software for systems architec-ture, design and modeling

● IBM Rational Quality Manager software for life cyclequality management from requirements, to build, to testcases and defects

● IBM Rational Team Concert™ software for integratedversion control, automated work flows, and build capabilitiesenabling real-time visibility and complete project collaboration.

Use modeling to validate requirements, architecture and design throughout the development process

Manage all system requirements with traceability across the life cycle

Collaborate across diverse engineering disciplines and development teams

Best-in-class capabilities, integrated on a common platform

Achieve “quality by design” with an integrated, automated testing process

Innovation through collaboration

IBM Rational Rhapsody®

Continually prioritize investments based on marketplace demand, revenue potential, risk and cost

IBM Rational Focal Point™

IBM Rational DOORS® IBM Rational Quality Manager

IBM Rational Team Concert™

Collaborate Automate Improve

Figure 1: Rational solutions to help manage FDA regulatory compliance

8 Managing FDA regulatory compliance with IBM Rational solutions

Portfolio, product and project managementSolutions that help to align products and projects to business and stakeholder priorities to improve the pre-dictability of product success. IBM Rational portfolio, product and project management solutions help companiesunderstand the market needs and measure the business value,cost, and risk of proposed and/or delivered products. Theyhelp to align product investments with business objectives,improve predictability and product success, manage and optimize project execution, and measure team performanceand project results. Rational Focal Point software fosters pri-oritization of investments based on revenue potential, risk, andcost. It can be leveraged to gather and use stakeholder input toprioritize products, applications, and projects. Prioritizing theright products and maintaining clear visibility into perform-ance across the product life cycles can help companies defineand meet product and solution strategies and more accuratelytrack and predict returns on investments.

Requirements management and definitionSolutions that help to define and manage requirements toreduce rework, demonstrate compliance, and minimizecosts and risks. Rational solutions can help address concernsrelated to product innovation such as improving time to market and achieving return on investments. Throughrequirements traceability, development teams can tracerequirements to (and from) system requirements to test andrisk analysis results facilitating more accurate business analysisand demonstration of compliance. In a recent industry study,organizations surveyed incurred a cost of as much as 60 percent on time and budget when they used poor require-ments practices. Organizations with poor business analysiscapabilities had three times as many project failures as successes.2 When requirements are defined and managedproperly, project overruns can be significantly reduced by lowering the number of inaccurate, incomplete, and omittedrequirements.

Rational DOORS software is a leading requirements manage-ment solution that can help reduce costs, increase efficiencyand improve quality by managing requirements collection,control, communication, collaboration and verification. Theuse of its integrated requirements design environment canhelp manage traceability of your compliance and regulatoryneeds throughout the design and implementation life cycle.

Rational DOORS software design control templates builtagainst FDA design control inspectional techniques can jump-start projects subject to FDA regulations. Rational DOORSsoftware attributes can be used to properly classify and manage risks and hazards as required by the FDA. RationalDOORS software maintains requirement and specificationrecords of the design process which can demonstrate how your design and development plans are met by verification andvalidation plans and how risks can be mitigated.

Using Rational DOORS software, traceability reports andmatrices can be produced in a fraction of the time that itwould take to produce them manually. Most importantly,Rational DOORS software maintains a full audit trail on allchanges: what was and what is, user ID and date/time stampsof changes so that the design history file is created automati-cally as users go about their work of entering data and creatinglinks. Electronic sign off is also available.

Integrated collaboration, change and configurationmanagementIntegrated change and configuration control, and automated work flows enabling real-time cross-teamcommunication and collaboration for rapid response tochange. The solution is integrated on the IBM Jazz™ plat-form which is suited to global and distributed teams. The Jazzplatform can help transform systems and software delivery bymaking it more collaborative, productive, and transparent.IBM Rational Team Concert software is the collaborativeengine of the solution, coordinating the system engineeringtasks and workflows; all governed by a customizable team

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workflow process. Requirements from Rational DOORS software can be linked to work items in the Rational TeamConcert tool: this linkage helps developers or stakeholdersreview the requirements linked to a work item. The work item type may be a requirements change request, an imple-mentation task, a defect, or other standard or custom workitem type.

FDA regulation guidelines require identification of the majordevelopment tasks to be undertaken, deliverables for each task,and individual or organizational responsibilities (staff andresources) for completing each task. The Rational TeamConcert tool integrates stakeholders, project leads, and sys-tems engineers to facilitate compliance to FDA requirementsfor a quality design control process. It offers the collaborativetask environment and automated change control processrequired by medical device developers and life sciences teams

to manage FDA quality systems regulations and design controlchange management guidelines. Project dashboards in theRational Team Concert software can help further improveproject tracking through transparency and reporting of teamstatus and project health. Dashboards present live project andplan information in tabular or graphical form further facilitat-ing the control over the development process while also providing flexibility and agility in team workflows. The teambuild component in Rational Team Concert software implements a standardized and controlled build process andprovides build awareness, control, and traceability to the soft-ware engineering team and the software test team. Teams canalso expect improved configuration management to controlproduct content as required by the FDA controls for designdocumentation and artifacts.

Figure 2: Demonstrate compliance by ensuring full traceability of requirements using Rational DOORS

10 Managing FDA regulatory compliance with IBM Rational solutions

“ The Rational tools help us enforce ourprocesses and our procedures, so the devel-opers can be writing code as efficiently asthey can, the whole project team, startingwith the requirements all the way throughto the test results.”

—Jim Ring, Tools and Methods Practitioner Principal, Blue Cross Blue Shield3

Design and developmentSolutions that help model, design, and build resilientarchitectures for today’s most innovative products, systems, software and systems of systems. Architecturaldecisions and design activities are supported by IBM RationalRhapsody software. Rational Rhapsody software offers capa-bilities for modeling system and software requirements, as well as developing and delivering the software components. It provides an easy-to-use yet rigorous environment for thecreation, management, and execution of both SysML andUML models.

Rational Rhapsody software is a visual development environ-ment for systems engineers and software developers creatingreal-time or embedded systems and software. RationalRhapsody software helps diverse teams collaborate to under-stand and elaborate requirements, and abstract complexityvisually using industry standard languages. Rational Rhapsodysoftware provides medical device engineers with a collabora-tive development environment with simulation for earlyrequirements, architecture and behavioral validation, fosteringbetter understanding of complex requirements and trade-offanalysis of complex systems.

The intent of the FDA quality system requirements is that theproduct’s conceptual description be elaborated, expanded, andtransformed into a complete set of design input requirementswhich are written to an engineering level of detail. RationalRhapsody software can facilitate meeting the intent of thisregulation. FDA regulations require procedures for the formalreview and documentation of the evolution of the design andidentification of concerns and potential design issues. RationalRhapsody software helps capture design evolution and itspowerful simulation abilities support design reviews and helpin the early identification and capture of potential designissues.

Quality managementSolutions that help teams advance productivity and quality across the entire life cycle. IBM Rational QualityManager software provides a collaborative environment fortest planning, construction, and execution, supporting contin-uous testing as well as test management of system validationand acceptance testing. IBM Rational Test Lab Manager soft-ware can help improve the efficiency of system test labs andhelp manage how test resources are requested and provided.

FDA regulations are very much focused on verification andvalidation (V&V). A defined and controlled process isrequired. V&V planning, reviews, methods and results allmust be documented and linked to changes or correctiveactions that result from testing. Rational Quality Managersoftware links test artifacts across the life cycle so that trace-ability to and from requirements, change requests, develop-ment tasks and development artifacts may all be traced. AndRational Quality Manager software also facilitates effectiveworkflow control, tracking, and traceability features for testand verification. Using the Rational Quality Manager softwaredashboards (Figure 3), testers can review the systems qualitymetrics and project status, which may include tasks assigned inRational Team Concert software, requirements defined inRational DOORS software or software integration buildsready to be tested.

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Figure 3: Effective test management using Rational Quality Manager, integrates test planning and execution with requirements

SummaryThe Rational solutions for systems and software engineeringcan assist with reaching FDA compliance goals through inte-gration, collaboration, automation and reporting. The solu-tions support the creation and management of life-cycle workproducts necessary to fulfill FDA regulations and guidelines.The solutions provide a core set of best-in-class tools andprocesses for systems and software engineering teams, facili-tating engineering collaboration with unprecedented highlevel of transparency of project progress, control of artifacts,traceability with audit trails, task management and changecontrol.

The Rational solutions address the FDA identified lack ofdesign controls as one of the major causes of device recalls by:

● Maintaining design control specifications in a central, automated repository

● Providing design control specifications using customizabledocument templates

● Facilitating the design control process models, attributes andreports

● Maintaining up-to-date traceability matrices● Facilitating change impact analysis and capturing design

history● Managing compliance.

Please Recycle

About the authorKim Roberts, Industry Solution Executive, IBM RationalKim is a member of a specialized IBM Rational Industry TigerTeam for software and systems development focused on thehealthcare, medical device, electronics and life sciences indus-tries. Kim’s expertise is in development life cycle managementprocesses, tools and deployment. In her role as an IndustrySolution Executive, Kim works closely with clients to buildstrategies to help tackle industry, regulatory and business challenges that are derived from establishing and modernizingquality software and systems development processes whilemaintaining compliance with various standards and regulationssuch as CMMI, HIPAA, ICD10, cGMP, FDA, EuropeanMedical Device Directives and Quality Systems Regulations.Over the last 15 years, Kim has participated directly on product development teams and in support of complex clientimplementations using IBM Rational/Telelogic solutions.

For more informationTo learn more about the IBM Rational solutions for thehealthcare and life sciences industries, contact your IBM representative or IBM Business Partner, or visit:ibm.com/software/rational/solutions/healthcare/

Additionally, financing solutions from IBM Global Financingcan enable effective cash management, protection from technology obsolescence, improved total cost of ownershipand return on investment. Also, our Global Asset RecoveryServices help address environmental concerns with new, more energy-efficient solutions. For more information onIBM Global Financing, visit: ibm.com/financing

© Copyright IBM Corporation 2010

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Produced in the United States of AmericaNovember 2010All Rights Reserved

IBM, the IBM logo, ibm.com, DOORS, Jazz, Rhapsody, Rational, SmarterPlanet and planet icon are trademarks of International Business MachinesCorp., registered in many jurisdictions worldwide.

Other product and service names might be trademarks of IBM or other companies. A current list of IBM trademarks is available on the web at “Copyright and trademark information at information” atibm.com/legal/copytrade.shtml

References in this publication to IBM products or services do not imply that IBM intends to make them available in all countries in whichIBM operates.

The information contained in this documentation is provided forinformational purposes only. While efforts were made to verify thecompleteness and accuracy of the information contained in thisdocumentation, it is provided “as is” without warranty of any kind, expressor implied. In addition, this information is based on IBM’s current productplans and strategy, which are subject to change by IBM without notice.IBM shall not be responsible for any damages arising out of the use of, orotherwise related to, this documentation or any other documentation.

Nothing contained in this documentation is intended to, nor shall have the effect of, creating any warranties or representations fromIBM (or its suppliers or licensors), or altering the terms and conditions of the applicable license agreement governing the use of IBM software.

IBM customers are responsible for ensuring their own compliance withlegal requirements. It is the customer’s sole responsibility to obtain adviceof competent legal counsel as to the identification and interpretation ofany relevant laws and regulatory requirements that may affect thecustomer’s business and any actions the customer may need to take tocomply with such laws.

1 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

2 http://www.batimes.com/articles/the-impact-of-business-requirements-on-the-success-of-technology-projects.html

3 http://www-01.ibm.com/software/success/cssdb.nsf/cs/CCLE-82XVLA?OpenDocument&Site=corp&ref=crdb

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