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EtQ
Announces Software for Electronic
Submissions to the FDA |
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FARMINGDALE,
NY (03-18-07): EtQ,
Inc. has released the beta
version of the EtQ Reliance
eMDR Submission Tool, enabling
Medical Device Manufacturers
to electronically submit
Medical Device Reports (MDRs)
to the Food and Drug Administration
(FDA).
EtQ Reliance for Medical
Device is the leading
Quality Management system,
designed to identify,
mitigate and prevent high-risk
events using automation,
integration, and collaboration.
This methodology allows
companies to electronically
automate the quality process
for medical device, and
comply with quality and
compliance standards,
including those of the
FDA.
Part of the FDA's
regulations state that
if a firm receives complaints
on a device malfunction,
or a injury, illness,
or death associated with
a medical device, they
must report this incident
to the FDA. This report,
known as an adverse event
report (Form 3500A), is
currently submitted manually
to the FDA.
The FDA is working on an
electronic submission program
called "eMDR." This program
will enable companies to
submit MDRs to the FDA gateway,
a secure agency portal for
electronic submissions.
Working with representatives
from the FDA, EtQ has developed
a tool that will allow users
to electronically submit
MDRs to the FDA gateway,
seamlessly and efficiently.
Using the EtQ Reliance
eMDR Submission Utility,
not only are users able
to automatically submit
their reports directly
to the FDA, but it also
provides a level of functionality
that ensures fewer submission
errors, tying the submission
process directly into
the Complaints Handling
and CAPA workflows. "Using
the eMDR Submission Utility,
our users are able to
automate the FDA submission
so it is done faster and
with much less chance
of errors," says
Morgan Palmer, CTO of
EtQ. "Data collected
by our system is imported
directly into the electronic
submission form, which
is then submitted automatically
to the FDA. There is no
double-entry of information,
and the overall process
leads to faster response
times to critical events
within the system."
The FDA's eMDR
Submissions program is
currently in the pilot
phase, and EtQ is one
of the few solution providers
in the market participating
in this program. EtQ is
currently working with
several customers on its
eMDR Submission Utility,
all of whom are planning
to use the tool to electronically
submit MDRs once the FDA
pilot phase is completed.
About
EtQ
EtQ is the leading Enterprise
Quality and Compliance Management
Software for identifying,
mitigating and preventing
high-risk events through
integration, automation
and collaboration. EtQ uses
best in class, integrated
modules and enterprise application
integration to manage and
measure quality and compliance
processes and execute organizational
change. Key modules within
the product include: Document
Control, CAPA (Corrective
and Preventive Action),
Audits, Complaint Handling,
Risk Management, Change
Management, Employee Training,
Nonconforming Materials,
Enterprise Reporting and
more than 20 additional
compliance-oriented modules.
With its world class flexible
workflow, collaborative
platform EtQ has developed
a unique niche to support
enterprises involved in
various compliance management
initiatives such as; cGxP
(FDA), ISO 13485, ISO 9000:2000,
ISO/TS 16949, ISO 14001,
AS 9001, TL 9000, OHSAS
18001, RoHS and similar
standards for compliance
and regulatory management.
EtQ has been providing compliance
solutions to a variety of
markets for over fifteen
years.
For more information or
to schedule a virtual demo,
contact EtQ Inc., at 800-354-4476
or 516-293-0949, or e-mail
us at
.
Contact:
Tim Lozier
EtQ, Inc.
800.354.4476 ext. 19
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EtQ
is a trademark of EtQ
Management Consultants,
Inc. All other product
names and company names
are trademarks or registered
trademarks of their respective
owners. This release is
intended for informational
purposes only.
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