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FDA Compliance Software Solutions for Blood Services |
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The quality and safety of
the blood supply is of the
utmost importance. Between
donor quality, suitable
blood testing, and adhering
to strict FDA and AABB standards,
the Blood Services industry
must maintain strong quality
and FDA compliance systems.
The FDA has significantly
increased oversight of blood
centers and transfusion
centers, and as a result,
the blood industry must
maintain compliance to applicable
regulations (for example,
21 CFR parts 600, 606, 210-211
and 11). Having an FDA
Compliance Software
system in place that can
adapt to the changing regulatory
environment, while being
flexible enough to match
evolving business processes
is key in the blood banking
industry. |
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Challenges
Facing the Blood Services Industry |
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Collaborative,
Enterprise Environment
Large blood services 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 blood
services 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 blood
services 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 blood
services 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
blood services 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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