Your SlideShare is downloading. ×
0
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Armedia fda cstar doc man_content gov_alfresco_20130305
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Armedia fda cstar doc man_content gov_alfresco_20130305

1,214

Published on

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
1,214
On Slideshare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
1
Comments
0
Likes
1
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 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 2
  • 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 3 Page 3
  • 4. Armedia Clients March 13, 2013 Page 4
  • 5. Armedia Alfresco Government Clients March 13, 2013 Page 5
  • 6. About FDA CDRH March 13, 2013Center for Devices and Radiological Health (CDRH) is responsible for protectingand promoting the public healthResponsible for ensuring the safety and effectiveness of medical devices andeliminating unnecessary human exposure to the man made radiation frommedical, occupational and consumer productsProvide consumers, patients, their caregivers, and providers withunderstandable and accessible science-based information about the productsFacilitate medical device innovation by advancing regulatory science, providingindustry with predictable, consistent, transparent, and efficient regulatorypathways, and assuring consumer confidence in devices marketed in the U.S. 6 Page 6
  • 7. Business Governance March 13, 2013The Food and Drug Administration Safety and Innovation Act (Public Law 112-144)includes the Medical Device User Fee Amendments of 2012, or MDUFA IIIMedical device companies pay fees to FDA when they register their establishment andlist their devices with the agency, whenever they submit an application or a notificationto market a new medical device in the U.S. and for certain other types of submissionsMDUFA III represents a commitment between the U.S. medical device industry and theFDA to increase the efficiency of regulatory processes in order to reduce the time ittakes to bring safe and effective medical devices to the U.S. marketUnder 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 hascommitted to meet certain performance goals based on the timeliness of reviews 7 Page 7
  • 8. Business Objectives March 13, 2013Continue efforts to improve its IT systems with a future expectation of facilitatingavailability of real-time status information for submissionsAll review documentation and correspondence related to a pre-market submissions tobe stored electronicallyReplace handwritten signatures with Digital signatures for FDA review records andcorrespondence to applicantsIncorporate an interactive review process to provide for, and encourage, informalcommunication between FDA and applicants to facilitate timely completion of thereview process based on accurate and complete informationCapture, store and report on Industry and FDA Staff; Interactions during Review ofMedical Device Submissions 8 Page 8
  • 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 9 Page 9
  • 10. Why Armedia + Alfresco Delivery Team March 13, 2013 Increase Success Probability Alfresco Federal Partner Past Performance Key Personnel Reach-back to vendor 10 Page 10
  • 11. March 13, 2013 MDUFA IIIMedical Device Companies Submissions Review Submissions Interactive Review E-mail 11 Page 11
  • 12. Phase 1 - Solution March 13, 2013DocMan 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 participantsIntegration • 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 foldersMigration 12 Page 12
  • 13. Business Objectives March 13, 2013Continue efforts to improve its IT systems with a future expectation of facilitatingavailability of real-time status information for submissionsAll review documentation and correspondence related to a pre-market submissions tobe stored electronicallyReplace handwritten signatures with Digital signatures for FDA review records andcorrespondence to applicantsIncorporate an interactive review process to provide for, and encourage, informalcommunication between FDA and applicants to facilitate timely completion of thereview process based on accurate and complete informationCapture, store and report on Industry and FDA Staff; Interactions during Review ofMedical Device Submissions 13 Page 13
  • 14. CDRH DocManSOLUTION DEMO 14
  • 15. Keys to Success March 13, 2013 Demos throughout Plan for hiccups Iterative Roadmap Stakeholder involvement Delivery Team 15 Page 15
  • 16. QUESTIONS 16

×