Document and Quality Management Solutions for Life Sciences

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Prudence Johnston
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1 Document and Quality Management Solutions for Life Sciences

2 Company Overview Global Provider Established US and European footprint Proven Solution SharePoint based document and quality management. Solutions for Quality, Regulatory, Clinical and Corporate Market Leader More than 60 FDA regulated customers; including major pharmaceutical companies, biotech firms, medical device companies, CROs, and laboratories Main Offices King of Prussia, PA Munich, Germany US Regional Offices New York, NY Raleigh, NC San Diego, CA Irvine, CA Seattle, WA Columbus, OH British Columbia, Canada European Offices Paris, France London, England Microsoft Gold Certified Partner Managed Partner, SharePoint Advisory Council, MOSS 2007, SharePoint 2010 Launch Partner Compliance Certification ISO 9001 certified, as well as adherence to 21 CFR Compliance guidelines

CROs, and laboratories Main Offices King of Prussia, PA Munich, Germany US Regional Offices New York, NY Raleigh, NC San Diego, CA Irvine, CA Seattle, WA Columbus, OH British Columbia, Canada

Corporate Growth and Market Expansion Global Solutions Provider Strong North American Base Europe Expansion FDA Regulated Market Focus Industry Knowledge Life

3 Corporate Growth and Market Expansion Global Solutions Provider Strong North American Base Europe Expansion FDA Regulated Market Focus Industry Knowledge Life Science Domain Experience Deep Technology Insight Regulatory Compliance Consistent Growth From 10 to 60+ clients From 15 to 60+ employees Client Referenceability 3

Life Science Domain Experience Deep Technology Insight Regulatory Compliance

Gartner Magic Quadrant for Enterprise Content Management (ECM) Microsoft SharePoint moved from Niche to Visionary Leader between 2007 and 2009.

4 Gartner Magic Quadrant for Enterprise Content Management (ECM) Microsoft SharePoint moved from Niche to Visionary Leader between 2007 and Of all the infrastructure vendors, Microsoft has driven the most change in the ECM market over the past 24 months. By delivering a broad set of functionality using an infrastructure approach, Microsoft has changed the way organizations think about content management and collaboration. 4

Of all the infrastructure vendors, Microsoft has driven the most change in the ECM market over the past 24

5 Why Start with SharePoint? Baseline content management functionality is built-in, reducing cost and complexity Very familiar and easy-to-use interface, which results in easy adoption Emerging as the de facto content management standard, which reduces risk and aligns with corporate IT directions SharePoint becoming as ubiquitous as Microsoft Office products Large partner ecosystem Major SharePoint Migrations Abbott, AstraZeneca, Eli Lilly, Merck SharePoint Online GSK, Novartis and Baxter 5

interface, which results in easy adoption Emerging as the de facto content management standard, which reduces risk and

6 Core NextDocs Principals Pre-configured modules that can be deployed quickly dramatically improve ROI User adoption is the key to getting the impact desired Out-of-the-Box software solutions need to be matched with packaged implementation services Customization of software drives cost and risks exponentially higher Point solutions that require extensive integration result in very high costs of ownership An integrated platform with plug-compatible modules is essential for reducing complexity and costs 6

Customization of software drives cost and risks exponentially higher Point solutions that require extensive integration result

7 The NextDocs Compliance Suite

8 Regulatory Clinical Open Architecture Template-Based Customized Complete Out-of-the-Box Solutions for Life Sciences CAPA Audit Deviations Complaints Quality NextDocs Compliance Platform SharePoint Collaboration and Content Management Platform SOP 8

Sciences CAPA Audit Deviations Complaints Quality NextDocs

9 The Regulatory Submission Documents Module 9

The Regulatory Module Submission content management Folder Structures Document Templates Standard Workflows for Reviews and Approvals Integration with ectd submission vendors Regulatory Submission

10 The Regulatory Module Submission content management Folder Structures Document Templates Standard Workflows for Reviews and Approvals Integration with ectd submission vendors Regulatory Submission Document Management Smart Document Wizard Document Inventory ectd Connector ectd Archiving ectd Submission integration with following vendors: 10

------------------------------- Smart Document Wizard -------------------------------- Document Inventory

11 Standard Metadata Taxonomy The DIA SIAC EDM Reference Model combines functional areas with domains to combine to create a flexible and extensible taxonomy 11

12 DIA EDM reference model Integration The DIA EDM reference Model is an initiative being driven by a DIA committee that, according to its charter says, that the time has come for our industry to develop a taxonomy/metadata reference model for electronic document management. It allows companies to leverage a standard set of structures rather than developing their own information structures.. By leveraging a standard implementation methodology, the EDM reference model is readily employed in Life Sciences deployments in an open and sustainable manner. Using standard system configuration capabilities the EDM reference model provides a consistent taxonomy for the creation of document types, folders, categories and attributes within an ECM system. Also a requirement of the DIA EDM reference model is the need to include corporate taxonomy requirements, and to adapt to changes in the EDM reference model. 12

. By leveraging a standard implementation methodology, the EDM reference model is readily employed in Life Sciences deployments in an open and sustainable manner.

13 NextDocs is shipped with DIA EDM Reference Model or preferred folder structure

14 Quality and Standard Operation Process Management 14

Quality Management Module Out-of-the-box quality functions SOP Document Lifecycle Publishing Printing Control Training Acknowledge Quiz Control Smart Wizard Creation Forms-based Corrective and

15 Quality Management Module Out-of-the-box quality functions SOP Document Lifecycle Publishing Printing Control Training Acknowledge Quiz Control Smart Wizard Creation Forms-based Corrective and Preventative Actions (CAPA) tracking Deviation management Closed-loop complaint tracking Audit action item tracking Quality Documents Standard Operating Procedures Employee Training Records Processes CAPA Deviations Complaints Audits 15

action item tracking Quality Documents Standard Operating Procedures --------------------------------------- Employee Training Records Processes

16 Integration of Quality Processes is the Key to Gaining Quality Benefits Observed Deviations Audit Findings Complaints Risk Assessment And Categorization Corrective and Preventive Action (CAPA) PROCESS Change Management SOP Documentation Training 16

Complaints Risk Assessment And Categorization Corrective and

17 CAPA process The basic CAPA process is well understood and documented. but systems tend to focus on documentation far more than process Best Practices: Managing a CAPA System MDDIJ une 2006 Barbara K. Immel 17

18 Typical Problems with Automated CAPA Systems Adoption Automated CAPA systems are often separate environments, with unique interfaces, and not integrated into everyday process Mass Generation of CAPAs without Differentiation Without effective risk analysis and categorization, an organization can be overwhelmed with documented CAPAs Open Loop, Open CAPAs CAPAs have to be DRIVEN to resolution through workflow process and monitoring Lack of Integration When a CAPA solution is not part of an integrated quality solution connecting complaints, deviations, audits etc the benefits are highly diluted 18

can be overwhelmed with documented CAPAs Open Loop, Open CAPAs CAPAs have to be DRIVEN to resolution through workflow process and monitoring Lack of

19 The Clinical Documents Module 19

The Clinical Module Trial Master File Essential Study Documents Safety Documents and Notifications Secure Extranet Collaboration Investigator Portal CTMS Integration Clinical Clinical Portal

20 The Clinical Module Trial Master File Essential Study Documents Safety Documents and Notifications Secure Extranet Collaboration Investigator Portal CTMS Integration Clinical Clinical Portal Secure Authentication Account Self Service Portal/Trial Provisioning Site Start-up etmf CTMS Integration 20

Authentication -------------------------------- Account Self Service ------------------------------- Portal/Trial

21 The Next Phase of Technology Adoption in Clinical Trials epro, IVRS etc EDC CTMS Trial Master File Investigator Portal Manage the Documentation Manage the Collaboration 21

22 Challenges of a Paper-Based Trial Master File User Adoption Paper Handling Costs Audit-ability and Regulatory Risk Content Transformation Costs Obstacles to etmf Business: Lack of Industry-standard TMF models Investigator resistance Lack of defined and unified business processes Technology: 21 CFR Part 11 Extranet access Multiple file types Review and Approval 22

23 Compliant Collaboration across boundaries Secure Extranet Collaboration Compliant Collaboration Regulated document mgmt. Enterprise document mgmt. Enterprise metadata mgmt. Real-time collaboration Legacy systems & applications Across Boundaries Internal and external users Business partners Across geographies Across business entities Single-Sign On 21 CFR Part 11 compliance Collaborative Extranets Scientist Clinical Research Partners Principal Investigator Management Regulatory Subsidiary Companies Licensing Partners 23

24 24 NextDocs Cloud Services

25 NextDocs High Availability Cloud Services NextDocs High Availability Cloud Services Offerings As with a locally deployed environment users will only need to have a browser to access their hosted NextDocs solutions. NextDocs Shared SaaS Options Software as a Service (SaaS) is a subscription based or pay as you go model for licensing software. With SaaS, the licenses are paid for on a month to month basis. This solution scales as your business grows making planning for the future easier and more straight forward. NextDocs Dedicated With NextDocs Dedicated Hosting, your environment is built and managed on dedicated hardware in our remote world class SunGard datacenter facility. NextDocs Dedicated Hosting High Availability With NextDocs Dedicated Hosting with High Availability, your environment is mirrored in two remote SunGard datacenter facilities. This ensures peace of mind for businesses that need the highest level of redundancy for their critical applications and services. 25

26 Summary PLATFORM: SHAREPOINT INDUSTRY LEADING TECHNOLOGY EASE OF USE & TRAINING INCREASED USER ACCEPTANCE PARTNER: NEXTDOCS MOST SELECTED, MOST INSTALLED PROVEN IN PRODUCTION USE 100% REFERENCEABILITY PRODUCT: SOLUTION SCALABLE AND EXTENDABLE INDUSTRY BEST PRACTICES BUSINESS PROCESS OPTIMIZED PROJECT: SUPPORT/FLEXIBILITY DEEP INDUSTRY KNOWLEDGE BUSINESS & TECHNICAL APTITUDE COMPLIANCE ACCELERATORS 26

ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013

ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 TM ComplianceSP TM on SharePoint Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 Overview With increasing pressure on costs and margins across Life Sciences, the industry