NextDocs Regulatory Document Management Webinar 041211

Apr 12, 20110 likes792 views

This document summarizes a presentation about managing regulatory documents and processes with SharePoint 2010 and NextDocs. It discusses NextDocs as a global provider of SharePoint-based document and quality management solutions for regulatory, clinical, quality, and corporate areas. It notes challenges in the life sciences industry around increased drug development costs and timelines. It then describes NextDocs solutions for collaboration and control of compliant content through a compliance suite built for regulatory submissions with automated production of submission-ready documents and integration with publishing tools for an easy implementation aligned with regulatory requirements.

Managing Regulatory Documents & Processes w/
SharePoint 2010 & NextDocs

April 12th, 2011

Erik Smith – VP of NA Sales and Alliances
Kathie Clark – Director of Product Management

1

NextDocs Corporate Overview

Global Provider
• Established US, EU and Asia footprint
Proven Solution
• SharePoint-based document and quality
management. Solutions for Regulatory,
Clinical, Quality, and Corporate business
areas
Market Leader
• More than 85 FDA regulated customers;
including major pharmaceutical
companies, biotech firms, medical device
companies, CROs, and laboratories
Compliance Certification
• ISO 9001 certified, as well as complete
Global Headquarters US Regional Offices European Offices
adherence to 21 CFR Part 11 guidelines
King of Prussia, PA New York, NY Paris, France
Munich, Germany Raleigh, NC London, England Microsoft Gold Certified Partner
San Diego, CA
Irvine, CA Asia Offices
• Managed Partner, SharePoint Advisory
Seattle, WA Japan Council, MOSS 2007 and SharePoint 2010
Columbus, OH Launch Partner, 2010 Life Sciences
British Columbia, Canada Innovation Award Recipient, 2010 Life
Sciences Partner of the Year

Recent NextDocs Recognition

NextDocs named #52 on prestigious INC. 500 List – placing
#1 for the Philadelphia Metropolitan area and #5 in the
Software Industry category.

Awarded the Microsoft 2010 Life Sciences Partner of
the Year at the recent Microsoft Worldwide Partner
Conference in D.C

NextDocs named #1 on the Philadelphia 100 as the most
successful, fastest growing, privately owned business across
all verticals and all business segments in the region.

Named a 2010 Microsoft Innovation Award Winner for work
with Stanford University Hospital & Clinics on deployment of
NextDocs SOP Module

Life Science Industry Challenges

• Increased Drug Development Time and Cost:
• 10 – 15 years = average time to bring a new drug to market
• $1B+ = average cost to bring a new drug to market
• Increase regulatory scrutiny & adherence to requirements
• Does the drug provide increased or enhanced efficacy…?
• Does the drug provide better safety…?

• Plus, Internal Process Improvements:
• 90% = amount of corporate memory existing on paper
• 15% =average time spent reading factual content
• 50% = average time spent searching for content
• 19 = average number of times document gets copied
• 25% = annual document growth rate

Life Science Industry Challenges

• Need for Collaboration and Control of Compliant Content:
• The lack of a centralized, globally accessible platform to manage and store
essential study documentation
• Inconsistent document management processes across the organization
and between organizations
• Inconsistent or incomplete work assignments
• Inefficient notification of key events requiring follow-on action
• Incomplete, missing, expired or redundant documentation
• Other technical, administrative or security related obstacles

Lack of an effective document management system can lead to loss of
expert knowledge, inconsistent procedures and processes, re-work,
flawed decision making, and missed deadlines, all of which ultimately
translate to increased costs.

Kathie Clark
Regulatory Dome Management
Demonstration
Demonstration

10

Summary

INDUSTRY ISSUES
DRUG DEVELOPMENT TIME & COSTS CONTINUE TO INCREASE
OPERATIONAL EFFICIENCIES MUST INCREASE
MANY CLIENTS ARE STILL WRESTLING WITH MANUAL OR HYBRID PROCESSES

BUILT FOR SUBMISSIONS
AUTOMATED PRODUCTION OF SUBMISSION READY DOCUMENTS
eCTD ARCHIVING
INTEGRATION W/ ALL PUBLISHING TOOLS

EASE OF IMPLEMENTATION
CONFIGURED NOT CUSTOMIZED
ALIGNMENT W/ DIA REFERENCE MODEL
ADHERENCE TO REGULATORY REQUIREMENTS

Document, Quality & Clinical Operation
Solutions for Life Sciences
�ݺ�ߣs
amehta@nextdocs.com

Questions
esmith@nextdocs.com
kclark@nextdocs.com

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NextDocs Regulatory Document Management Webinar 041211

1. Managing Regulatory Documents & Processes w/ SharePoint 2010 & NextDocs April 12th, 2011 Erik Smith – VP of NA Sales and Alliances Kathie Clark – Director of Product Management 1

2. NextDocs Corporate Overview Global Provider • Established US, EU and Asia footprint Proven Solution • SharePoint-based document and quality management. Solutions for Regulatory, Clinical, Quality, and Corporate business areas Market Leader • More than 85 FDA regulated customers; including major pharmaceutical companies, biotech firms, medical device companies, CROs, and laboratories Compliance Certification • ISO 9001 certified, as well as complete Global Headquarters US Regional Offices European Offices adherence to 21 CFR Part 11 guidelines King of Prussia, PA New York, NY Paris, France Munich, Germany Raleigh, NC London, England Microsoft Gold Certified Partner San Diego, CA Irvine, CA Asia Offices • Managed Partner, SharePoint Advisory Seattle, WA Japan Council, MOSS 2007 and SharePoint 2010 Columbus, OH Launch Partner, 2010 Life Sciences British Columbia, Canada Innovation Award Recipient, 2010 Life Sciences Partner of the Year

3. Recent NextDocs Recognition NextDocs named #52 on prestigious INC. 500 List – placing #1 for the Philadelphia Metropolitan area and #5 in the Software Industry category. Awarded the Microsoft 2010 Life Sciences Partner of the Year at the recent Microsoft Worldwide Partner Conference in D.C NextDocs named #1 on the Philadelphia 100 as the most successful, fastest growing, privately owned business across all verticals and all business segments in the region. Named a 2010 Microsoft Innovation Award Winner for work with Stanford University Hospital & Clinics on deployment of NextDocs SOP Module

4. Life Science Industry Challenges • Increased Drug Development Time and Cost: • 10 – 15 years = average time to bring a new drug to market • $1B+ = average cost to bring a new drug to market • Increase regulatory scrutiny & adherence to requirements • Does the drug provide increased or enhanced efficacy…? • Does the drug provide better safety…? • Plus, Internal Process Improvements: • 90% = amount of corporate memory existing on paper • 15% =average time spent reading factual content • 50% = average time spent searching for content • 19 = average number of times document gets copied • 25% = annual document growth rate

5. Life Science Industry Challenges • Need for Collaboration and Control of Compliant Content: • The lack of a centralized, globally accessible platform to manage and store essential study documentation • Inconsistent document management processes across the organization and between organizations • Inconsistent or incomplete work assignments • Inefficient notification of key events requiring follow-on action • Incomplete, missing, expired or redundant documentation • Other technical, administrative or security related obstacles Lack of an effective document management system can lead to loss of expert knowledge, inconsistent procedures and processes, re-work, flawed decision making, and missed deadlines, all of which ultimately translate to increased costs.

6. NextDocs Solutions

7. The NextDocs Compliance Suite

8. The NextDocs Compliance Suite

9. The NextDocs Compliance Suite

10. Kathie Clark Regulatory Dome Management Demonstration Demonstration 10

11. Summary INDUSTRY ISSUES DRUG DEVELOPMENT TIME & COSTS CONTINUE TO INCREASE OPERATIONAL EFFICIENCIES MUST INCREASE MANY CLIENTS ARE STILL WRESTLING WITH MANUAL OR HYBRID PROCESSES BUILT FOR SUBMISSIONS AUTOMATED PRODUCTION OF SUBMISSION READY DOCUMENTS eCTD ARCHIVING INTEGRATION W/ ALL PUBLISHING TOOLS EASE OF IMPLEMENTATION CONFIGURED NOT CUSTOMIZED ALIGNMENT W/ DIA REFERENCE MODEL ADHERENCE TO REGULATORY REQUIREMENTS

12. Upcoming Webinars 12

13. Document, Quality & Clinical Operation Solutions for Life Sciences �ݺ�ߣs amehta@nextdocs.com Questions esmith@nextdocs.com kclark@nextdocs.com

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NextDocs Regulatory Document Management Webinar 041211

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