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EMC Documentum Enterprise Compliance Platform for the Life Sciences Overcoming operational challenge and risk

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EMC Documentum Enterprise Compliance Platform for the Life Sciences

Overcoming operational challenge and risk

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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

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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.

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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

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.