armedia fda cstar doc man_content gov_alfresco_20130305
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Center for Devices and Radiological Health (CDRH) Document
Manager (DocMan) March 5, 2013
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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April 11, 2023About Armedia
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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April 11, 2023Armedia Clients
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April 11, 2023Armedia Alfresco Government Clients
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April 11, 2023About FDA CDRH
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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April 11, 2023Business Governance
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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April 11, 2023Business Objectives
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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April 11, 2023Why FDA CDRH chose Alfresco
• Alfresco has attractive entry level pricing
• Alfresco cost per user scales very well
• The delivery team was able to demonstrate key use cases using Alfresco in the POC
• Alfresco supports open standards like CMIS
• Alfresco can scale with organization
• Alfresco has industry recognition
• Alfresco is being adopted in Government
Reputation Open Platform
EconomicsProof of Concept
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April 11, 2023Why Armedia + Alfresco Delivery Team
Increase Success Probability
Alfresco Federal Partner
Past Performance
Key Personnel
Reach-back to vendor
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April 11, 2023
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MDUFA III
Medical Device Companies
Review Submissions
Submissions
Interactive Review
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April 11, 2023Phase 1 - Solution
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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April 11, 2023Business Objectives
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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SOLUTION DEMOCDRH DocMan
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April 11, 2023Keys to Success
Delivery Team Stakeholder involvementIterative Roadmap
Plan for hiccups Demos throughout
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QUESTIONS
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