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Blood
and Tissue
Good
manufacturing practice (GMP) regulations Part 606, CLIA
'88 requirements, increased regulations from the FDA
for unlicensed blood establishments and transfusion
services, competition within the blood banking profession,
and increased cost pressures have changed the way the
blood banking community conducts its business. In today's
competitive environment, conducting business in a quality
framework is no longer an option, but a must*.
Part
of a quality assurance program includes maintaining
and calibrating equipment and instruments, such as thermometers
and centrifuges, and documenting those events to satisfy
regulatory requirements.
Blue
Mountain Regulatory Asset Manager is a browser-based
solution for companies that are looking to improve collaboration
across multiple groups involved with the management
of assets. It combines all the unique features required
by maintenance personnel, including work requests and
inventory management, with all the features required
by calibration personnel, including standards traceability
and measurement data collection, in a single package
that eliminates duplicated data entry on shared assets.
With
everyone involved with the asset using the same application,
notifications can be sent to all groups impacted by
specific activity. This quick response can make a big
difference in getting equipment back up and running
quickly.The
configurable approval routing system can even keep records
from being used that have not been reviewed by the appropriate
personnel.
With
the state-of-the-art architecture of Blue Mountain Regulatory
Asset Manager companies can install the software at
one facility or for an entire organization.
A
computerized system used in the manufacturing process
must perform properly. Blue Mountain Quality Resources
provides a complete Validation Protocol for all its
products with the test scripts and guidelines to prove
the effective functional use of the software. Blue Mountain
also provides other validation resources, including
a Software Quality Assurance Manual, training, and on-site
validation.
*www.aabb.org
- "Accreditation Program"
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