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  • 1.  Center  for  Devices  and   Radiological  Health  (CDRH)  Document  Manager  (DocMan)    March  5,  2013          
  • 2. 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   2
  • 3. About  Armedia   March  6,  2013  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   3   Page 3
  • 4. Armedia  Clients     March  6,  2013   Page 4
  • 5. Armedia  Alfresco  Government  Clients     March  6,  2013   Page 5
  • 6. About  FDA  CDRH   March  6,  2013  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.   6   Page 6
  • 7. Business  Governance   March  6,  2013  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   7   Page 7
  • 8. Business  Objec.ves   March  6,  2013  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   8   Page 8
  • 9. Why  FDA  CDRH  chose  Alfresco   March  6,  2013   • Alfresco  has  industry   • Alfresco  supports   recogni.on   open  standards  like   • Alfresco  is  being   CMIS   adopted  in   • Alfresco  can  scale   Government   with  organiza.on   Open   Reputa.on   PlaXorm   Proof  of   Economics   Concept   • The  delivery  team   • Alfresco  has   was  able  to   ajrac.ve  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  6,  2013   Increase  Success  Probability   Alfresco  Federal  Partner   Past  Performance   Key  Personnel   Reach-­‐back  to  vendor   10   Page 10
  • 11. March  6,  2013   MDUFA IIIMedical Device Companies Submissions Review Submissions Interactive Review E-mail 11   Page 11
  • 12. Phase  1  -­‐  Solu.on   March  6,  2013  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   12   Page 12
  • 13. Business  Objec.ves   March  6,  2013  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   13   Page 13
  • 14. CDRH  DocMan  SOLUTION  DEMO   14  
  • 15. Keys  to  Success   March  6,  2013   Demos   throughout     Plan  for   hiccups   Itera.ve   Roadmap   Stakeholder   involvement   Delivery   Team   15   Page 15
  • 16. QUESTIONS   16