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FDA Compliance for Biotechnology |
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FDA Compliance Software
for Biotechnology |
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The Biotechnology industry
encompasses several types
of companies, including
those working in energy,
agriculture, food science,
and medicine, producing
a variety of products. Biotechnology
is involved in many leading
edge life science technologies
(from cancer drugs to DNA
research), and must maintain
regulatory compliance across
multiple regulating bodies,
including the FDA, the EPA
and the USDA.
Biotechnology regulatory
requirements can fall under
many categories, and are
often regulated by more
than one agency. Pharmaceutical-based
biotechnology industries
must maintain compliance
to the applicable FDA
regulations, and quality management
or environmental
based biotechs may also
choose to adopt ISO
9000 and ISO
14001 systems. Having
an FDA
Compliance Software
system to maintain compliance
to the variety of regulatory
requirements, and adapting
to business processes is
very important to biotechnology. |
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Challenges
facing the Biotechnology Industry |
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Collaborative,
Enterprise Environment
Large biotechnology 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 biotechnology
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 biotechnology
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 Compliance, a secure environment
must be maintained, and the biotechnology
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
biotechnology 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 Management
and FDA Compliance
Management Software systems
in the market.
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