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Managing Regulatory Documents & Processes w/
SharePoint 2010 & NextDocs
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April 12th, 2011
Erik Smith – VP of NA Sales and Alliances
Kathie Clark – Director of Product Management
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 adherence to 21 CFR Part 11 guidelines
Microsoft Gold Certified Partner
• Managed Partner, SharePoint Advisory Council, MOSS 2007 and SharePoint 2010 Launch Partner, 2010 Life Sciences Innovation Award Recipient, 2010 Life Sciences Partner of the Year
Global Headquarters 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 Asia Offices Japan
NextDocs Corporate Overview
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
Named a 2010 Microsoft Innovation Award Winner for work with Stanford University Hospital & Clinics on deployment of NextDocs SOP Module
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.
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.
NextDocs Solutions
The NextDocs Compliance Suite
The NextDocs Compliance Suite
The NextDocs Compliance Suite
Regulatory Dome Management
Demonstration
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Demonstration
Kathie Clark
Summary
INDUSTRY ISSUES
DRUG DEVELOPMENT TIME & COSTS CONTINUE TO INCREASE
OPERATIONAL EFFICIENCIES MUST INCREASE
MANY CLIENTS ARE STILL WRESTLING WITH MANUAL OR HYBRID PROCESSES
EASE OF IMPLEMENTATION
CONFIGURED NOT CUSTOMIZED
ALIGNMENT W/ DIA REFERENCE MODEL
ADHERENCE TO REGULATORY REQUIREMENTS
BUILT FOR SUBMISSIONS
AUTOMATED PRODUCTION OF SUBMISSION READY DOCUMENTS
eCTD ARCHIVING
INTEGRATION W/ ALL PUBLISHING TOOLS
Upcoming Webinars
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Document, Quality & Clinical Operation
Solutions for Life Sciences
Slides [email protected]
Questions
