The
impetus to go
electronic may well
have been FDA's
mandate that as of
June 2009 the agency
will only accept
electronic
submissions. Even
though the last day
to file a paper
submission was 31
Dec 2007, many
companies managed to
get waivers. So the
new mandate has
spurred the decision
to go fully
electronic for more
than one firm. With
that decision comes
a whole spate of
issues.
Electronic
systems require
four essentials:
validation,
security, audit
trails, and
accountability.
None of these
are clear cut,
and companies
still struggle
to make sense of
the very vague
Part 11
regulation -
which itself was
slated for
revision by 2006
to focus on
risk, but
industry has yet
to see it. The
current,
original final
rule provides
little help in
the actual "how
to" for bringing
a system on
board, and more
than one company
has found itself
mired in the
transition
process after
having selected
a suitable
vendor, agreed
to contractual
terms, and
purchased a
configurable off
the shelf (COTS)
software
program.
If
the company has
thought through
the requirements
it needs in an
electronic
document
management
system, it has
done its
homework and
selected a
system that is
optimum for its
business needs.
Yet such a
foundation does
not guarantee
that the company
will implement
the system
efficiently.
The
transition can
be a torment, or
it can be
efficient,
depending on
several factors.
The first is
getting people
on board and
actively
involved in the
process. The
second is being
systematic in
validating for
"intended
performance".
The third is
training. And
the fourth is
building the
repository for
documents and
records within
the system.
With
an electronic
system, the
company has
entered into a
relationship
with the vendor.
It is important
that the
workforce knows
this. Enthusiasm
from the top
down from the
start of the
process -
ideally when the
decision to
purchase an
e-system is made
- helps bring
people on board.
The knowledge
that the system
will be easy to
use, save time,
and pay for
itself in short
order are
benefits the
users need to
know and
understand. The
people who made
the decision to
purchase a
software program
are the ones who
need to
communicate with
the workforce.
That means upper
management who
authorized the
purchase must be
vocal and
visible in
endorsing the
system. Those
who participated
in selecting it
and understand
its features
should be
advocates as
well. Indeed,
those people who
participated in
the process are
the ideal people
to form a
validation team,
because they are
the very ones
who understand
"intended
performance"
best and can
drive the
transition.
Making
the Transition to an
E-System 