The document discusses a presentation given to the FDA's Center for Devices and Radiological Health (CDRH) about implementing an Alfresco-based document management system called DocMan. It provides background on Armedia, the company pitching the solution, an overview of CDRH's goals to improve electronic recordkeeping and collaboration around medical device submissions, and details of the proposed Phase 1 DocMan solution which would streamline reviews and integrate with other systems.

1. Center for Devices and
Radiological Health (CDRH)
Document Manager (DocMan)
March 5, 2013

2. Agenda
• Introduction
– About Armedia
– About FDA CDRH
• Business Governance
• Business Objectives
• Why Alfresco
• Why Armedia + Alfresco Delivery Team
• Concept of Operations
• Phase 1 - Solution
• Solution Demo
• Questions
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3. About Armedia March 13, 2013
 Services:
 Design and Implementation of Enterprise Content / Case / Record
Management solutions
 Primary technologies: Alfresco, EMC Documentum, IBM
FileNet, Microsoft SharePoint and Oracle UCM
 Solutions and Frameworks:
 Armedia Caliente – Bulk multi-platform content migration tool
 Armedia Case Management – Case Management framework that can
be used to quickly develop an intuitive solutions
 Government & Commercial Past Performance
 CMMI Level 3 appraised
 8(a)/SDB, Veteran owned, and 50+% staff carry a TS clearance
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4. Armedia Clients March 13, 2013
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5. Armedia Alfresco Government Clients March 13, 2013
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6. About FDA CDRH March 13, 2013
Center for Devices and Radiological Health (CDRH) is responsible for protecting
and promoting the public health
Responsible for ensuring the safety and effectiveness of medical devices and
eliminating unnecessary human exposure to the man made radiation from
medical, occupational and consumer products
Provide consumers, patients, their caregivers, and providers with
understandable and accessible science-based information about the products
Facilitate medical device innovation by advancing regulatory science, providing
industry with predictable, consistent, transparent, and efficient regulatory
pathways, and assuring consumer confidence in devices marketed in the U.S.
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7. Business Governance March 13, 2013
The Food and Drug Administration Safety and Innovation Act (Public Law 112-144)
includes the Medical Device User Fee Amendments of 2012, or MDUFA III
Medical device companies pay fees to FDA when they register their establishment and
list their devices with the agency, whenever they submit an application or a notification
to market a new medical device in the U.S. and for certain other types of submissions
MDUFA III represents a commitment between the U.S. medical device industry and the
FDA to increase the efficiency of regulatory processes in order to reduce the time it
takes to bring safe and effective medical devices to the U.S. market
Under MDUFA III, the FDA is authorized to collect user fees that will total approximately
$595 million (plus adjustments for inflation) over five years. In exchange, the FDA has
committed to meet certain performance goals based on the timeliness of reviews
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8. Business Objectives March 13, 2013
Continue efforts to improve its IT systems with a future expectation of facilitating
availability of real-time status information for submissions
All review documentation and correspondence related to a pre-market submissions to
be stored electronically
Replace handwritten signatures with Digital signatures for FDA review records and
correspondence to applicants
Incorporate an interactive review process to provide for, and encourage, informal
communication between FDA and applicants to facilitate timely completion of the
review process based on accurate and complete information
Capture, store and report on Industry and FDA Staff; Interactions during Review of
Medical Device Submissions
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9. Why FDA CDRH chose Alfresco March 13, 2013
• Alfresco has industry • Alfresco supports
recognition open standards like
• Alfresco is being CMIS
adopted in • Alfresco can scale
Government with organization
Open
Reputation
Platform
Proof of
Economics
Concept
• The delivery team • Alfresco has
was able to attractive entry level
demonstrate key use pricing
cases using Alfresco • Alfresco cost per user
in the POC scales very well
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10. Why Armedia + Alfresco Delivery Team March 13, 2013
Increase Success Probability
Alfresco Federal Partner
Past Performance
Key Personnel
Reach-back to vendor
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11. March 13, 2013
MDUFA III
Medical Device
Companies
Submissions
Review
Submissions
Interactive Review
E-mail
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12. Phase 1 - Solution March 13, 2013
DocMan Solution
• Submission Business Rules. Generate a Submission taxonomy based on
submission metadata
• When Submissions are created, automatically associate email addresses
• Give business users control over taxonomy templates and metadata
• Streamline review collaboration between Statisticians, Physicians, Chemist,
and Mathematicians
• Dynamic security based on participants
Integration
• Single Sign On (SSO) – AD/Kerberos authentication
• E-mail - Capture e-mail communication and attachments into Alfresco
• Center Tracking System (CTS) – Create and view submission folders
Migration
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13. Business Objectives March 13, 2013
Continue efforts to improve its IT systems with a future expectation of facilitating
availability of real-time status information for submissions
All review documentation and correspondence related to a pre-market submissions to
be stored electronically
Replace handwritten signatures with Digital signatures for FDA review records and
correspondence to applicants
Incorporate an interactive review process to provide for, and encourage, informal
communication between FDA and applicants to facilitate timely completion of the
review process based on accurate and complete information
Capture, store and report on Industry and FDA Staff; Interactions during Review of
Medical Device Submissions
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14. CDRH DocMan
SOLUTION DEMO
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15. Keys to Success March 13, 2013
Demos
throughout
Plan for
hiccups
Iterative
Roadmap
Stakeholder
involvement
Delivery
Team
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16. QUESTIONS
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