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FDA Compliance Software Solutions for Medical Devices |
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In the highly competitive
Medical Device market, only
the most innovative and
cost-effective products
will survive. Success in
this industry requires adherence
to applicable FDA regulations
(such as 21 CFR 820 and
21
CFR Part 11), and may
also involve meeting ISO
standard requirements
(such as ISO
13485:2003). Rapid product
development processes providing
responsiveness to changing
market demands are key to
meeting the demands of this
market.
Device Manufacturers are
challenged with maintaining
Quality
Management systems that
can adapt to the changing
market needs, provide tools
to shorten product development
lifecycles, manage the supply
chain, and are compliant
with a wide range of regulatory
requirements. Having an
FDA Compliance
Software system to maintain
compliance to the variety
of regulatory requirements,
and adapting to business
processes is very important
to the medical device industry. |
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Challenges
facing the Medical Device Industry |
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Collaborative,
Enterprise Environment
Large medical device industries
with multiple divisions typically
have independent, hybrid systems
in place. Bridging the gap between
these systems is inefficient in
the long-term, and ultimately
will require expensive customizations
to link the enterprise. Re-routing
documents, meeting to discuss
integration strategy, and IT man-hours
in customizations result in lost
time and money. EtQ's
FDA Compliance Software is
designed to incorporate the whole
enterprise in collaborating at
the enterprise level, while maintaining
each division's independent business
workflow.
The result is a unified Quality
Management system that allows
for each division to collaborate
with the enterprise.
Unified
Quality Process
Too often, business processes
are disconnected, with complaint
handling forms, SOPs and the like
not connected to the next phase
in the record's life cycle. EtQ's
FDA Compliance Software allows
the process to be linked automatically
and intelligently. Complaint
handling forms are assessed,
investigated, and opened as a
CAPA if
needed. SOPs are linked to the
employee
training database, and assignments
are sent. Risk
Assessment tools assess the
risk of records throughout the
process. This unified process
for handling FDA
compliance issues results
in an efficient system, where
no time is lost and no problem
overlooked.
Contract
Manufacturing
As more companies rely on Contract
Manufacturers to bring their medical
device products to market, it
is important that the systems
implemented allow for increased
visibility downstream. EtQ's
FDA Compliance Software provides
integration
at multiple levels of the process,
allowing contract manufacturers
to take part in the overall medical
device industry, without direct
access to the main system. This
allows the Contract Manufacturers
to fill in their pieces of the
process, and provide a seamless
Quality Management
system, from start to finish.
Validation
As required by 21
CFR Part 11, a secure environment
must be maintained, and the medical
device industry must be validated
to maintain electronic signature
integrity. As a result, validation
services can double, or even
triple the cost of a software
system. EtQ's
FDA Compliance Software is
designed specifically for the
medical device industry, and our
staff has developed the test scripts
necessary to ease system
validation. Because EtQ's
FDA Compliance Software is
usable right out of the box, and
configurations are executed at
the server level, the need to
extensive validation across the
enterprise is less than comparative
Quality
and FDA Compliance
Management Software systems
in the market.
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