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EMC Documentum Enterprise Compliance Platform for the Life Sciences
Overcoming operational challenge and risk
Life sciences: Navigating an uncertain futureNot long ago, a GlaxoSmithKline annual report opened with an interesting device. It posed five
“questions that matter” and then spent the next eight pages answering them.1 Nearly every life sciences
company must surely be asking itself the first question on the list: “How are you adapting your business
model to succeed in the current healthcare environment?”2 That question will always be relevant to
life sciences companies. The future is grim for companies that don’t successfully answer it.
Of course, the current environment is challenging, but the life sciences industry has always been a
rollercoaster ride—a feast or famine of profit and risk. For example, in a primarily upbeat letter to
shareholders in Genentech’s 1996 annual report, Chairman and CEO Arthur Levinson remarked that
earnings were “restrained” due to aggressive spending in R&D—almost 50 percent of 1996 revenues.3
So, it’s always been tough. But it’s getting tougher still. Today’s life sciences organization confronts
four arduous operational challenges.
Pricing pressure and shrinking profit marginsAs PriceWaterhouseCoopers points out on its website, drugs do not represent a large share of overall
healthcare costs—around nine percent in the U.S., which is lower than most developed countries. Yet
they are a prime cost reduction target for healthcare organizations. Governments also exert downward
pressure on drug prices with restrictive reimbursement policies. Pharma companies can still demand
premium prices for blockbuster drugs with proven safety and established efficacy. But these products
are becoming few and far between for most companies.
Thinning development pipelinesExpiring patents mean increased competition from generics. The sales of Eli Lilly’s Prozac declined 80
percent within months of generic competitors entering the market in late 2001. This is a harsh reminder
of the damage that can be done when a drug’s market exclusivity is lost.
Outsourcing of clinical trials to reduce costsLife sciences companies are under unrelenting pressure to increase the commercialization rate across
their clinical trial portfolios. But clinical trials are more complex than ever. They are conducted globally
across time zones, hundreds of investigational sites, and thousands of participants. To deal with trials
on such a massive scale, large pharmaceutical companies frequently outsource trials to clinical research
organizations (CROs) and other partners. Yet this process adds significant complexity to trial management,
which can drastically reduce whatever cost savings global, outsourced trials may promise. Plus, the
more complex the trial procedures, the greater the possibility that a procedural error may invalidate
results, resulting in additional cost and lost revenue
Increasing and more complex regulatory requirementsThe life sciences industry is global and so is the regulatory scrutiny intended to control it. Sales and
marketing practices as well as privacy of patient and customer information are the principal targets
of heightened attention. For example, standard sales and marketing practices in foreign countries are
often in direct conflict with the anti-bribery and accounting requirements of the Foreign Corrupt Practices
Act4. This increased regulatory pressure has put life sciences companies on notice. They need to
address information governance, risk, and compliance at a global level.
1 GlaxoSmithKline. 2007 Annual Report. Brentford, Middlesex, United Kingdom: GlaxoSmithKline 2007. Five Questions. Five Answers. One Mission.2008. 8 December 2008 <http://www.gsk.com/investors/reps07/annual-report-2007.pdf>
2 Ibid.
3 Genentech. 1996 Annual Report. South San Francisco, California: Genentech 1996. Letter to Stockholders.1997. 8 December 2008 <http://www.gene.com/gene/ir/financials/annual-reports/1996/pdf/stkhldrs.pdf>
4 PriceWaterhouseCoopers, “Managing Regulatory Compliance.” http://www.pwc.com/extweb/industry.nsf/docid/72824F7B6398B357852570590020A7E8 (accessed December 16, 2008).
indecision informed decision
EMC Documentum Enterprise Compliance Platform for Life SciencesEMC understands the life sciences market. By design, the EMC® Documentum® Enterprise Compliance
Platform for Life Sciences meets the complex needs of this industry. Enterprise Compliance Platform
includes four components that deliver unprecedented control, visibility, and flexibility for managing
content and processes in a complex, team-oriented environment:
•Complianceinterface
•Processservices
•Contentservices
•Repositoryservices
Compliance interfaceEMC Documentum Compliance Manager, EMC Documentum Retention Policy Services, and EMC Documentum
Collaboration Services make up the compliance interface. Compliance Manager enables staff to use
automated lifecycles and workflows with built-in business rules to govern the review and approval,
effective, retired, and obsolete life cycle states for all regulatory content. Retention Policy Services
adds integrated, audited retention management capabilities for content created in Compliance Manager
or in any other Documentum application. The compliance interface also features collaborative workspaces
that enable knowledge workers to plan and execute projects with extended enterprise teams and
standards-based integration with popular content authoring tools.
Process servicesProcess services can be applied to virtually any process including disease/condition modeling, pre-clinical
study definition, NDA submissions, quality management, and packaging. Even within a process that
cannot be fully automated, process services can automate many manual repetitive tasks. All activity
within a process is captured via an audit trail, which not only serves compliance purposes but also
captures best practices and metrics for continued process improvement.
Content servicesEnterprise Compliance Platform content services automate the creation, management, sharing, assembly,
tracking, and delivery of controlled and regulated content within an audited, tightly managed environment.
They enable control of all types of content including case report forms, SOPs, label information, contracts,
product documentation, and regulatory submissions. Content lifecycles maintain control over content
and users while enforcing business rules that support compliance with good manufacturing practices
(GMP), OSHA regulations, ISO 9000 quality guidelines, 21 CFR Part 11, and others.
Repository servicesThe core functions of repository services are records management and intelligent storage management.
Documentum records and retention management are unobtrusive and easy to use. For example, end
users can declare and classify records from within Microsoft Outlook, as well as other user interfaces.
Intelligent storage management makes business-critical data available when and where it’s needed and
meets service level agreements (SLAs) while reducing storage costs. Enterprise Compliance Platform
also gives users the option of adding EMC Documentum Information Rights Management , which helps
life science companies secure, control, and track sensitive information wherever it resides.
Extending the platformEMC has extended the functionality of the Enterprise Compliance Platform through its best-of-breed
approach to partnerships. The partner applications that we’ve described so far incorporate the power
and scalability of the platform with process-specific features and functionality. Many of these are
configurable, off-the-shelf solutions that can meet the immediate needs of small and mid-sized life
sciences organizations. But they can also scale as companies grow and want to deploy them across a
greater number of departments.
EMC: Speeding commercialization while ensuring compliance
When pharmaceutical, biotech, and medical device companies effectively manage business processes
and regulated content throughout the product lifecycle, they accelerate development and speed
commercialization. EMC Documentum Enterprise Compliance Platform enables regulatory compliance
and good information governance while it:
•Optimizesprocessesandstreamlinesinformationsharingandcollaboration
•Seamlesslymanagesregulatedcontentthroughoutitslifecycle
•Supportspreconfiguredsolutionsforeaseofdeployment
•Consolidatesapplicationsandcontentviaacommonplatformandsecurevirtualrepository
•Reducesintegration,migration,andvalidationcosts
More than 200 of the world’s top life sciences organizations—including the 25 largest pharmaceutical
companies and seven FDA Centers—rely on EMC solutions. EMC can help life sciences companies exploit
the natural relationships between content and processes that start in discovery and pre-clinical research
and extend all the way to customer service—which means your business becomes more agile, more
responsive, and more competitive.
A partial list of EMC customers in the Life Sciences
Abbott Laboratories
Akzo Nobel
Alcon Laboratories
Allergan
Alza Corporation
AstraZeneca
Aventis
Baxter Healthcare Corporation
Bayer AG
Berlex Laboratories
Biogen Idec
Boehringer Ingelheim
Bracco SpA.
Bristol-Myers Squibb Company
Chugai Pharmaceutical
CommonHealth
Covance
Daiichi Pharmaceutical
FDA
Forest Laboratories
Guidant
Human Genome Services
Johnson & Johnson
Medlmmune
Millennium Pharmaceuticals
North America
Novartis
Novo Nordisk A/S
OSI Pharmaceuticals
Otsuka Pharmaceuticals
Pfizer
Purdue Pharma
Roche
Sankyo
Sanofi
Schering AG
Schering Plough
Shionogi & Co.
Takeda Pharmaceuticals
Vertex Pharmaceuticals
Wyeth Pharmaceuticals
EMC and its partners: Helping life sciences companies compete in a global marketplaceFortunately for life sciences companies, as the environment they operate in becomes more demanding,
complex, and risky, the evolution of technology solutions that can help has favored lighter weight,
standards-based architectures that enable a modular, services-based information infrastructure. This
type of infrastructure can support configurable solutions that deploy quickly “off the shelf,” without
coding or extensive customization. Yet, they are scalable—suitable for organizations of any size, from
small biotech startups with limited resources to massive, enterprise pharmaceutical companies with
operations around the globe and budgets to match.
The EMC Documentum Enterprise Compliance Platform for the Life Sciences provides just such an
information infrastructure, supporting the breadth of the life sciences value chain—from R&D,
preclinical, and clinical to manufacturing, sales, marketing, and compliance. Solutions from EMC and its
best-in-class partners leverage this platform to help life sciences organizations meet the challenges they
face, streamline operations, and increase sales. These solutions can enable your company to:
•Acceleratedrugdevelopmentandcommercialization
•Maintainhighsafetystandardsandbringdrugstomarketsafely
•Reducethecostsofregulatorycompliancewhileacceleratingsubmissions
•Facilitateinternalandexternalcollaboration
•Streamlineglobalclinicaltrialmanagement
•Reducethecostofmarketingtophysiciansandpatients
EMC has more experience providing solutions to life sciences organizations than any other enterprise
content management company. On the following pages, we profile solutions that touch every facet of
the life sciences enterprise.
disruptive constructive
EMC Documentum Solutions for Life Sciences
Solution: Good Information Governance and Collaboration for SharePoint
Valiance Partners
EMCThere’s no doubt that in the life sciences secure and reliable management of controlled content is essential
to ensure product quality, safety, and compliance. Nevertheless, the drive for greater productivity and
operating efficiency also puts a premium on enhancing collaboration across the controlled content
lifecycle, especially through leveraging Microsoft SharePoint’s simplicity and ease of use.
Transparent access to regulated content via SharePointVUpoint|DCM by Valiance Partners is a fully integrated, out-of-the-box solution that delivers all the
collaborative benefits of SharePoint with the proven compliance capabilities of EMC Documentum
Compliance Manager. Without additional customization, this affordable, rapidly deployable solution
complies with many of the worldwide regulatory requirements in the life sciences industry. It comes
complete with its own:
•Validationmasterplantemplate
•IQ/OQ/PQprotocolsandtestscripts
•Qualificationsummaryreporttemplate
•Tracematrix
VUpoint|DCM is eCTD ready and includes built-in audit trail and e-signature capabilities. For companies
that struggle to maintain efficiency while ensuring compliance with mandates such as FDA 21 CFR Part 11,
GxP processes, Sarbanes-Oxley, and others, VUpoint|DCM enables breakthrough cost performance and
time-to-ROI.
VUpoint|DCM has everything necessary to expedite production deployment—from functional requirements
and system design to validation and training. It combines the best of both worlds—off-the-shelf and
customized—in a single, highly effective, feature-rich product. VUpoint|DCM provides a complete turnkey
application that can be configured to the preferences and needs of any organization.
With VUpoint|DCM, SharePoint users enjoy transparent access to Compliance Manager services.
VUpoint|DCM’s SharePoint interface is completely seamless, enabling users to:
•CreatenewdocumentsfromComplianceManagertemplatesanddocuments
•InitiateComplianceManagerworkflows
•Leveragecontentmanagementfunctionalitysuchascheck-in/check-out,cancelcheck-out,view/edit
properties, and renditions
•Applydynamicwatermarksandgeneratereports
•SearchacrossComplianceManagerandSharePointrepositorieswithasinglequery
•Replacebookmarks
•Processinboxcontents
Valiance PartnersValiance Partners is a software, systems consolidation, and quality assurance company specializing in mission-critical and regulated business environments. The company’s expertise and products emphasize innovation, precision, and measurable results. Valiance helps organizations take greater advantage of their information assets and intellectual property, enhance quality and compliance, and create distinctive value for customers and shareholders alike.
Solution: Compliance-in-a-Box SOP Edition
Impact Systems
EMCFor many emerging life sciences companies, the enterprise content management applications for
controlled content are financially out of reach. Yet managing controlled content is crucial to improving
efficiency while reducing the cost and risk of the drug design and delivery process.
Integrated, scalable, affordableWhat these aspiring companies need is an integrated, affordable package of software, hardware, and
services to manage regulated content in a controlled and audited environment. To meet this need, EMC
and Impact Systems created Compliance-in-a-Box SOP Edition. Built on EMC Documentum Compliance
Manager, Compliance-in-a-Box SOP Edition is configured for SOP work processes and management. It
includes documentation and a test script package from Impact Systems and an Intel-based server for
rapid configuration and deployment. The result: A fully functioning, validated Documentum compliance
environment, ready to help mitigate risk, reduce liability, and meet the compliance requirements that
govern all life sciences organizations.
Compliance-in-a-Box SOP edition enables organizations to start small, scale quickly, and still retain the
ability to “think big” with respect to a long-term enterprise solution. The intent of Compliance-in-a-Box
is to get a working Documentum application up and running within four weeks—from installation in a
test environment to production implementation. The rapid installation and implementation of
Compliance-in-a-Box SOP Edition provide significant cost savings and reduced customer IT involvement,
accelerating return on investment.
With Compliance-in-a-Box SOP Edition, your organization can:
•Easilyrespondtoexternalregulatoryagenciesandinternalauditors
•Quicklydeterminewhohasinteractedwithcontent,when,andwhy
•Detectattemptstoalterorremovedocuments
•Enforcee-signaturerequirementsandproperapprovals
•Ensurecontentauthenticityandimmutability
•Complywithdocumentretentionpolicies
Impact SystemsImpact Systems develops world-class products and solutions for enterprise content management (ECM), making ECM easier to deploy, manage, and migrate. With over a decade serving start-ups, government agencies, Fortune 50 companies—and everything in between—Impact Systems provides products and services of exceptional quality and reliability.
Impact Systems makes ECM easier for its customers with proven, comprehensive content migration and deployment processes, and a proprietary suite of software tools. Using this solid foundation, solutions are tailored to meet individual business requirements and needs.
Solution: Compliance-in-a-Box Submission Edition
Impact Systems
Image Solutions, Inc.
EMCToday, the U.S. Food and Drug Administration accepts only electronic submissions in eCTD format. This
requirement went into effect on January 1, 2008 and, by the end of 2009, all regulatory agencies in the
EU are planning to adopt the eCTD format as well, while eliminating the paper requirement.
Mandatory electronic submissions are a fact of life for all life sciences companies. Large or small, they
must comply. Considering how quickly the pharmaceutical regulatory environment changes, controlled
content and electronic submissions solutions need to be agile as well as robust. It’s better to configure
and scale as needed than to rip and replace in the future.
Designed to meet the shifting regulatory demands of today’s life sciences organizationEMC, Impact Systems, and Image Solutions, Inc. created Compliance-in-a-Box Submission Edition to
combine power, flexibility, and scalabity. Compliance-in-a-Box Submission Edition enables companies
to configure, install, and validate an integrated, regulated content management and electronic publishing
system—quickly with minimal startup costs. The solution and its underlying platform can scale as clinical
trials progress from the Investigational New Drug (IND) and New Drug Application (NDA) stages to
Marketing Authorization Application (MAA) and electronic submission.
The solution combines EMC Documentum Compliance Manager with Impact Systems’ preconfiguration
tools, templates, and document types. The solution also includes three products from ISI:
•eCTDXPress—forsubmittingcontentelectronicallytoregulatoryagencies
•ISIPublisher—forsupportingpaper-basedandnon-eCTDelectronicsubmissions
•VirtualLinkManager—formaintainingcross-documenthyperlinksevenwhenthesourceandtarget
documents have changed
Working with a team of experts, your organization can rapidly configure and implement the basic
Compliance-in-a-Box system, which can be extended to support additional document types, workflows,
and business processes.
With Compliance-in-a-Box Submission Edition you can:
•Managepreclinical,clinical,Chemistry,Manufacturing,andControls(CMC),andregulatorycontenttypes
•Extendmanagementtosafety,legal,andaccountingcontentforsupportofSarbanes-Oxleyand
financialreporting
•Enforcee-signatureswhileensuringcontentauthenticityandretention
•Controlcontentaccesswithtiereduserpermissionsandquicklyidentifycontentinteractions
•Createsubmission-readydocuments
•Publishelectronicallyorviaprint
•Captureelectronicrecordsandassuredestructionbasedonbusinessrules
Image Solutions, Inc. Image Solutions, Inc. (ISI) has played a pioneering role in the worldwide movement toward acceptance and standardization of PDF-based electronic submissions. Today, ISI is a recognized leader in the electronic submission of NDAs.
By designing, developing, implementing, and supporting advanced imaging technologies, ISI has assisted many of the world’s foremost pharmaceutical companies in reducing the time and cost associated with electronic NDA development, compilation, submission, and review. The company has arangeofexpertiseinworkflowdesign,projectmanagement,documentmanagement,medicalwriting, software design, development and training, and systems and software integration. ISI has also expandeditselectronicsubmissionsexpertisetothelegal,insurance,financialservices,publishing,and other regulated industries.
Solution: EMC Documentum solution for eTrial Master File
EMC Professional ServicesToday clinical trials are conducted globally; they often span time zones, involve hundreds of investigational
sites, and include thousands of participants. Amidst this complexity, establishing and maintaining a
trial master file (TMF) for regulatory documents and associated paperwork brings a host of challenges.
Despite the unquestioned need to accelerate, streamline, and simplify clinical trials management, life
sciences organizations continue to struggle with manual, paper-based processes that hamper trials at
every stage—increasing time, cost, and compliance risk. Many have developed electronic repositories,
but they are static repositories that lack the ability to manage information through the trial lifecycle or
maximize its usage with partners and internal stakeholders.
Reduced cycle time and compliance risk through enhanced collaborationThe EMC Documentum solution for eTrial Master File (eTMF) enables pharmaceutical companies to
unlock the hidden value of information for decision support, speeding drug development. It provides
business process services, automated workflow, secure collaboration, and streamlined publishing, all
of which help increase clinical trial yield and accelerate commercialization. The solution also features a
global, auditable, electronic document repository for the Essential Documents specified in ICH Good
Clinical Practices. Accessible through a customizable, web-based interface, Documentum eTMF enables
users to:
•Createadigitalmasterfilethatcanbecustomizedforlocalneedswhileprovidingsecure,remote
access for monitoring and updates
•Accelerateclinicaltrialstartupviaasecure,web-basedportalforinformationexchange
•Enablesecurecollaborationbetweensponsors,investigators,healthauthorities,ethicscommittees,
and contract research organizations
•Supportrapidandcollaborativedevelopmentofcommonreferencedocuments,includingthedata
management plan, monitoring plan, and statistical analysis plan
•Facilitatethecompletionandgatheringofdocuments,suchasform1572
•Leveragestandardtemplatestofacilitatedocumentauthoring,review,andapproval
•Viewkeydocumentsandmilestonessuchasprotocolfinalization,IRBapprovals,andmonitoring
trip reports in real time
•Eliminatethechallenges,costs,andrisksofpaper-basedtrialmasterfiles
•Reducecomplianceriskbysystematicallyaligningsponsorandsitefiles
•Providesecureremoteaccesstorequireddocumentsforfieldmonitorsandauditpersonnel
EMCEMC Corporation (NYSE: EMC) is the world’s leading developer and provider of information infrastructure technology and solutions that enable organizations of all sizes to transform the way they compete and create value from their information. Information about EMC’s products and services can be found at www.EMC.com.
Solution: Structured Product Labeling
Glemser Technologies
EMCPharmaceutical product labeling content, such as package inserts, summaries of product characteristics,
andcoredatasheets,mustbesubmittedtotheFDAinastandardizedXMLformatcalledStructuredProduct
Labeling (SPL). Each revision to a labeling document can involve numerous editors and approvers who must
comply with mandates prescribing access controls, audit trails, and annotation tracking. Labeling content
also changes frequently—two to three times per year on average per drug. With the recent introduction of
the FDA’s SPL Release 4, labeling requirements now include drug listing and registration information.
To address these demands, some companies use third-party conversion services or develop internal
processes to manually create and edit SPL files. These approaches may work, but they ultimately add
cost and complexity to a process that already has plenty of both. Deploying a content management
platform that directly addresses the business and regulatory requirements of labeling content is far
more effective. With this approach, companies can reduce cost, complexity, and compliance risk while
accurately managing the entire labeling process from creation through submission.
An out-of-the-box labeling solutionTo help life sciences organizations comply with product labeling regulations, EMC and Glemser Technologies
offer SPL for Documentum Compliance Manager—a complete, preconfigured, out-of-the-box content
management solution that addresses all relevant regulatory requirements for product labeling, including
the SPL Release 4 standard. Built on the Documentum 6.5 platform, SPL for Documentum Compliance
Manager is a set of feature extensions and configurations for the Compliance Manager application.
Designed for companies that need only comply with the SPL standard, it can easily be upgraded to
Glemser’s xmLabeling system, which offers complete support for global labeling processes, including
translations and the EMEA PIM standard. SPL for Documentum Compliance Manager enables life sciences
companies to:
•EnsurecompliancewithSPLandPIM
•GenerateacompleteSPLRelease4electronicsubmission
•Reducethetimetocreate,review,approve,andmanageproductlabelingdocuments
•ReducecostsbyleveragingtheComplianceManagerapplicationenvironment
•Increaseproductivitybyreplacingmanualprocedureswithautomatedworkflowsandelectronic
approvals
•Eliminateredundancybyreusingdocumentationcomponentsinmultiplelabelingdocuments
Glemser TechnologiesGlemser designs and implements content management solutions for life sciences companies. The company provides world-class consulting, implementation, and validation services as well as its own set of Documentum-based software applications.
Glemser uses classic systems development lifecycle methodology that enables the company to consistently deliver high-quality, enterprise software solutions that meet user needs and regulatory requirements. Its staff has the experience and the know-how to address complex business requirements and challenging technical environments. Glemser has successfully implemented IT solutions for some of the world’s largest global pharmaceutical companies.
Solution: Plant and Asset Management
McLaren Software
EMCEffective operation of a pharmaceutical processing plant depends on up-to-date engineering or CAD
drawings, related health and safety documents, maintenance manuals, SOPs, and as-built documents.
This documentation must be tightly controlled to ensure accuracy and compliance with industry regulations.
Moreover, regulators expect companies to prove that documentation follows an auditable set of
business processes.
Managing engineering documentation carries several challenges. First, its volume is staggering.
Documentation for a single asset can have many thousands of pieces. Second, managing as-built
documentation must accommodate modifications by different project and maintenance teams working in
parallel—synchronizing the final results. Third, industry regulations may require archiving documents for
as few as twenty years or as long as a hundred. Compliance violations can lead to fines and compensation
payments. Finally, incorrect documentation can create profit-eroding project delays and plant downtime.
An integrated solution for managing engineering documentationTogether, the EMC Documentum platform and the McLaren Enterprise Engineer application suite provide an
integrated solution for managing engineering documentation in the context of business processes. This
joint solution delivers access to vital engineering information and ensures that the right information is
available to authorized individuals throughout the design, construction, operation, maintenance, and
decommissioning of plants and other large assets.
McLaren Enterprise Engineer provides complete access to the Documentum platform’s content services.
It combines content services, such as workflow, lifecycle management, and audit trails, with packaged
business logic to deliver an engineering-specific solution. Enterprise Engineer also integrates with
EMC Documentum Records Manager and EMC Documentum Content Storage Services. Enterprise
Engineer enables engineering content to be distributed in multiple languages, over long distances,
and across internal and external systems.
The EMC and McLaren solution for plant and asset management provides:
•Enterprisemanagementofengineeringdocumentationandassociatedbusinessprocesses
•Controloverthecreation,review,andpublicationofengineeringcontent
•IntegrationwithMicrosoftOffice,AutodeskAutoCAD,andBentleySystemsMicroStation
•Reducedriskofplantdowntimeornoncompliancewithindustryregulations
•Supportforelectronicworkpackagesandthe21CFRPart11standardforelectronicsignatures
•EaseofaccesstoengineeringdocumentationviaMicrosoftSharePoint
McLaren SoftwareMcLaren Software develops intellectual work management applications that support the engineering business process. By improving the effectiveness with which engineering information is created, retrieved, and used, Enterprise Engineer can reduce costs, shorten project durations, and improve operational effectiveness.
Sincedeliveringitsfirstsoftwareproductsin1995,McLarenSoftwarehasatrackrecordofdevelopingquality solutions that meet the exacting requirements of companies in the process manufacturing, oil and gas, utilities, pharmaceutical, and engineering prime contractor markets. McLaren Software has ISO 9001:2000 accreditation for the supply of software and associated services.
EMC CorporationHopkintonMassachusetts01748-91031-508-435-1000In North America 1-866-464-7381www.EMC.com
EMC CorporationHopkintonMassachusetts01748-91031-508-435-1000In North America 1-866-464-7381www.EMC.com
EMC2, EMC, Documentum, and where information lives are registered trademarks or trademarks of EMC Corporation in the United States and other countries. All other trademarks used herein are the property of their respective owners. © Copyright 2009 EMC Corporation. All rights reserved. Published in the USA. 8/09 Brochure H4613
Take the next stepTo learn how EMC can deliver improved business performance to your life sciences organization, visit us online at http://www.emc.com/solutions/industry/healthcare-life-sciences/life-sciences.htm, call us at 1-866-438-3622, or e-mail [email protected]
Solution: Contact Center Management
RWD Technologies
EMCMedical call center managers face mounting pressure to cost effectively manage their customer service
operations, handle increased volumes of medical inquiries, and boost customer satisfaction in their
customer contact centers. Given the scope of functions many contact centers perform and the rigorous
regulatory scrutiny under which they operate, these are significant challenges. To meet them requires an
integrated management solution that streamlines the flow of information to key internal and external
stakeholders.
Integrated medical communications: Accurate, relevant information in real timeDeveloped on the Documentum content management platform, RWD infoMaestro supports the creation,
management, and fulfillment of standard response packages, while providing critical audit trails for
each inquiry. For example, the solution integrates Documentum and Siebel Customer Relationship
Management software to provide customer service representatives with a single interface through which
they can rapidly generate dynamic responses from approved content. Automated case routing to
pharmacovigilance and product complaint systems provides a single point of capture for critical
information. Response time shrinks from weeks to minutes while inquiries are fulfilled according to
customer preference. Operational costs and the risk go down and customer satisfaction soars.
RWD infoMaestro connects customers to relevant information on demand—minimizing delays and
reducing support costs. And it empowers employees to respond to inquiries in real time while it:
•Reducestheriskofnoncompliancethroughconsistentuseofcurrent,approvedinformationwithan
audit trail of contact, case, and inquiry details
•Streamlinesthecreation,review,andapprovalofstandardresponsesthrougheliminationof
manual, error-prone, and redundant processes
•Handlesincreasedinquiryvolumeswithoutsacrificingcustomerservicequalityorboostingstafflevels
•Automatestheassemblyandfulfillmentofresponsepackagesformultiplechannels,includingmail,
phone, fax, self-serve kiosks, websites, and e-mail
•Facilitatesseamlessinteractionwithinternalandexternalcustomersincludingtriage,pharmacovigilance,
and product complaint systems
RWD TechnologiesRWD develops, implements, and supports products and services used to deliver performance and continuous improvement, ERP consulting and training, advanced learning services, and business transformation and change management programs. The company focuses on increasing worker productivity,productquality,andbottom-linefinancialperformancethroughpeople,process,organization, and technology initiatives. RWD’s technology and training solutions increase operational efficiencyandreducecostsbystreamliningprocessesandprocedures.
RWD serves Fortune 500 and major multinational corporations around the world. Its solutions are usedinmorethan20industries,includingfinance,pharmaceuticals,petrochemicals,manufacturing,automotive, rail, telecommunications, healthcare, and consumer products.