Document and Quality Management Solutions for Life Sciences

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

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

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

• 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

Corporate Growth and Market Expansion

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Microsoft SharePoint moved from

Niche to Visionary Leader between 2007 and 2009.

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.

Gartner Magic Quadrant for Enterprise Content Management (ECM)

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

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Why Start with SharePoint?

Major SharePoint Migrations

Abbott, AstraZeneca, Eli Lilly, Merck

SharePoint Online GSK, Novartis and Baxter

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

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Core NextDocs Principals

The NextDocs Compliance Suite

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NextDocs Compliance Platform

Quality

SharePoint Collaboration and Content Management Platform

SOP Reg

ula

tory

Clin

ical

CAPA

Deviations

Audit

Open Architecture

Template-Based Customized Complete Out-of-the-Box Solutions for Life Sciences

Complaints

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The Regulatory Submission

Documents Module

Submission content management

Folder Structures

Document Templates

Standard Workflows for Reviews and Approvals

Integration with eCTD submission vendors

The Regulatory Module

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eCTD Submission integration with following vendors:

Submission Document Management

------------------------------- Smart Document

Wizard --------------------------------

Document Inventory --------------------------------

eCTD Connector --------------------------------

eCTD Archiving

Regulatory

Standard Metadata Taxonomy

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

DIA EDM reference model Integration

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• 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.

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

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Quality and Standard Operation Process

Management

Quality Management Module

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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

Standard Operating Procedures

--------------------------------------- Employee Training Records

CAPA --------------------------------------

Deviations --------------------------------------

Complaints --------------------------------------

Audits

Documents

Processes

Integration of Quality Processes is the Key to Gaining Quality Benefits

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Observed Deviations

Audit Findings

Complaints

Risk Assessment

And Categorization

Corrective and

Preventive Action (CAPA)

PROCESS

Change Management

SOP Documentation

Training

CAPA process

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Best Practices: Managing a CAPA System MDDIJ une 2006 Barbara K. Immel

The basic CAPA process is well understood and documented… …. but systems tend to focus on documentation far more than process

• 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

Typical Problems with Automated CAPA Systems

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The Clinical Documents Module

Trial Master File

Essential Study Documents

Safety Documents and Notifications

Secure Extranet Collaboration

Investigator Portal

CTMS Integration

The Clinical Module

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Clinical Portal -------------------------------- Secure Authentication

-------------------------------- Account Self Service

------------------------------- Portal/Trial Provisioning --------------------------------

Site Start-up --------------------------------

eTMF --------------------------------

CTMS Integration

Clinical

The Next Phase of Technology Adoption in Clinical Trials

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Trial Master File

EDC CTMS ePRO, IVRS etc

Manage the Documentation

Investigator Portal

Manage the Collaboration

User Adoption

Paper Handling Costs

Audit-ability and Regulatory Risk

Content Transformation Costs

Challenges of a Paper-Based Trial Master File

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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

Principal Investigator

Licensing Partners

Research Partners

Subsidiary Companies

Compliant Collaboration across boundaries Secure Extranet Collaboration

Compliant Collaboration • Regulated document mgmt. • Enterprise document mgmt. • Enterprise metadata mgmt. • Real-time collaboration • Legacy systems & applications

• 21 CFR Part 11 compliance

Across Boundaries • Internal and external users • Business partners • Across geographies • Across business entities • Single-Sign On

• Collaborative Extranets

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Scientist

Regulatory

Clinical

Management

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NextDocs 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.

NextDocs High Availability Cloud Services

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Summary

PRODUCT: SOLUTION

SCALABLE AND EXTENDABLE

INDUSTRY BEST PRACTICES

BUSINESS PROCESS OPTIMIZED

PARTNER: NEXTDOCS

MOST SELECTED, MOST INSTALLED

PROVEN IN PRODUCTION USE

100% REFERENCEABILITY

PLATFORM: SHAREPOINT

INDUSTRY LEADING TECHNOLOGY

EASE OF USE & TRAINING

INCREASED USER ACCEPTANCE

PROJECT: SUPPORT/FLEXIBILITY

DEEP INDUSTRY KNOWLEDGE

BUSINESS & TECHNICAL APTITUDE

COMPLIANCE ACCELERATORS

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