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FDA Compliance Software Solutions for Pharmaceuticals |
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From discovery to clinical
trials to patient delivery,
introducing pharmaceuticals
to market is often a long,
involved process. In addition
to the costs incurred in
obtaining FDA approval,
the expenditure to mass-produce
products for the market
can be substantial. Delays
in delivering new medicines
means lost revenue - to
the tune of millions of
dollars per day. This, coupled
with the initial R&D
investment (which can reach
over $700 million), makes
the business of introducing
new medicines an expensive
endeavor.
Staying on top of regulatory
requirements while producing
safe and effective products
is vital. More and more
companies are turning to
highly configurable, flexible
software systems to adapt
to the ever-changing regulatory
landscape. EtQ has developed
an FDA
Compliance Software Solution
to help pharmaceutical companies
maintain compliance to Current
Good Manufacturing Practice
(cGMP) and Electronic Signatures
and Records (21
CFR Part 11). The robust,
workflow-based system allows
for the automation of business
processes, without programming
or custom development. This
ensures a system that will
not only meet/exceed the
requirements of today's
regulations, but also be
flexible enough to meet
future needs. |
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Challenges
Facing the Pharmaceutical Industry |
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Collaborative,
Enterprise Environment
Large pharmaceutical 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 pharmaceutical
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 pharmaceutical
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 pharmaceutical
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
pharmaceutical 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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