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Center for Devices and Radiological Health (CDRH)
Document Manager (DocMan)
March 5, 2013
Agenda
• Introduc.on – About Armedia – About FDA CDRH
• Business Governance • Business Objec.ves • Why Alfresco • Why Armedia + Alfresco Delivery Team • Concept of Opera.ons • Phase 1 -‐ Solu.on • Solu.on Demo • Ques.ons
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March 6, 2013 About Armedia
ü Services: ü Design and Implementa.on of Enterprise Content / Case / Record
Management solu.ons ü Primary technologies: Alfresco, EMC Documentum, IBM FileNet,
MicrosoT SharePoint and Oracle UCM ü Solu5ons and Frameworks:
ü Armedia Caliente – Bulk mul.-‐plaXorm content migra.on tool ü Armedia Case Management – Case Management framework that can
be used to quickly develop an intui.ve solu.ons
ü Government & Commercial Past Performance
ü CMMI Level 3 appraised
ü 8(a)/SDB, Veteran owned, and 50+% staff carry a TS clearance
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March 6, 2013 Armedia Clients
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March 6, 2013 Armedia Alfresco Government Clients
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March 6, 2013 About FDA CDRH
Center for Devices and Radiological Health (CDRH) is responsible for protec.ng and promo.ng the public health
Responsible for ensuring the safety and effec5veness of medical devices and elimina5ng unnecessary human exposure to the man made radia5on from medical, occupa.onal and consumer products
Provide consumers, pa.ents, their caregivers, and providers with understandable and accessible science-‐based informa.on about the products
Facilitate medical device innova.on 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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March 6, 2013 Business Governance
The Food and Drug Administra.on Safety and Innova.on 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 applica.on or a no.fica.on 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 .me it takes to bring safe and effec.ve 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 infla.on) over five years. In exchange, the FDA has commiYed to meet certain performance goals based on the 5meliness of reviews
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March 6, 2013 Business Objec.ves
Con.nue efforts to improve its IT systems with a future expecta.on of facilita.ng availability of real-‐5me status informa5on for submissions
All review documenta.on and correspondence related to a pre-‐market submissions to be stored electronically
Replace handwrijen signatures with Digital signatures for FDA review records and correspondence to applicants
Incorporate an interac5ve review process to provide for, and encourage, informal communica.on between FDA and applicants to facilitate .mely comple.on of the review process based on accurate and complete informa.on
Capture, store and report on Industry and FDA Staff; Interac.ons during Review of Medical Device Submissions
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March 6, 2013 Why FDA CDRH chose Alfresco
• Alfresco has ajrac.ve 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 organiza.on
• Alfresco has industry recogni.on
• Alfresco is being adopted in Government
Reputa.on Open PlaXorm
Economics Proof of Concept
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March 6, 2013 Why Armedia + Alfresco Delivery Team
Increase Success Probability
Alfresco Federal Partner
Past Performance
Key Personnel
Reach-‐back to vendor
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March 6, 2013
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MDUFA III
Medical Device Companies
Review Submissions
Submissions
Interactive Review
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March 6, 2013 Phase 1 -‐ Solu.on
DocMan Solu5on • Submission Business Rules. Generate a Submission taxonomy based on submission metadata
• When Submissions are created, automa.cally associate email addresses • Give business users control over taxonomy templates and metadata • Streamline review collabora.on between Sta.s.cians, Physicians, Chemist, and Mathema.cians
• Dynamic security based on par.cipants
Integra5on • Single Sign On (SSO) – AD/Kerberos authen.ca.on • E-‐mail -‐ Capture e-‐mail communica.on and ajachments into Alfresco • Center Tracking System (CTS) – Create and view submission folders
Migra5on
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March 6, 2013 Business Objec.ves
Con.nue efforts to improve its IT systems with a future expecta.on of facilita.ng availability of real-‐5me status informa5on for submissions
All review documenta.on and correspondence related to a pre-‐market submissions to be stored electronically
Replace handwrijen signatures with Digital signatures for FDA review records and correspondence to applicants
Incorporate an interac5ve review process to provide for, and encourage, informal communica.on between FDA and applicants to facilitate .mely comple.on of the review process based on accurate and complete informa.on
Capture, store and report on Industry and FDA Staff; Interac.ons during Review of Medical Device Submissions
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SOLUTION DEMO CDRH DocMan
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March 6, 2013 Keys to Success
Delivery Team
Stakeholder involvement
Itera.ve Roadmap
Plan for hiccups
Demos throughout
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QUESTIONS
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