Document and Quality Management Solutions for Life Sciences

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 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

 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.

 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

5

Why Start with SharePoint?

Major SharePoint Migrations

Abbott, AstraZeneca, Eli Lilly, Merck

SharePoint Online

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

NextDocs Compliance Platform

Quality

SharePoint

Collaboration and Content Management Platform

SOP

R

egula

tor

y

Clin

ic

al

CAPA

Audit

Open Architecture

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

9

The Regulatory

Submission

 Submission content management

 Folder Structures

 Document Templates

 Standard Workflows for Reviews and

Approvals

 Integration with eCTD submission

vendors

The Regulatory Module

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

• 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

Quality and Standard

Operation Process

Quality Management Module

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 Out-of-the-box quality functions

 SOP

 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

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

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The Clinical

Trial Master File

Essential Study Documents

Safety Documents and

Notifications

Secure Extranet

Collaboration

Investigator Portal

CTMS Integration

The Clinical Module

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

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 23 Scientist Regulatory Clinical Management

• 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

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