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
2

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

Armedia
Clients
March
6,
2013
Page 4

Armedia
Alfresco
Government
Clients
March
6,
2013
Page 5

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

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

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

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

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

March
6,
2013
MDUFA III
Medical Device
Companies
Submissions
Review
Submissions
Interactive Review
E-mail
11
Page 11

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

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

CDRH
DocMan
SOLUTION
DEMO
14

Keys
to
Success
March
6,
2013
Demos
throughout
Plan
for
hiccups
Itera.ve
Roadmap
Stakeholder
involvement
Delivery
Team
15
Page 15

QUESTIONS
16