New Release of Blue Mountain Regulatory Asset Manager
Further Streamlines Workflow
and Reduces Costs to Implement
Blue Mountain Quality Resources (State College, PA) announced today a new release of Blue Mountain Regulatory Asset Manager. The new release provides quick ways to find and update information, as well as additional functionality to facilitate global multi-site roll outs and reduce the costs of small-scale implementations.
“When we add new functionality to Blue Mountain Regulatory Asset Manager it is always with the unique requirements of regulated life science companies in mind,” explained James Erickson, President and CEO of Blue Mountain Quality Resources, Inc. “Each new release is a result of feedback from throughout the pharmaceutical, biotech and medical device industries and this new release is no exception.”
For more information about the new functionality, visit www.coolblue.com/Products/whatsnew.htm.
Blue
Mountain sponsors web event to launch the ISPE
Good Practice Guide for Maintenance
April
30 , 2009 - Blue Mountain Quality Resources (State
College, PA) announced today their sponsorship
of the "Launch of the ISPE Good Practice Guide:
Maintenance - How to Develop a cGMP Maintenance
Program for Regulatory Compliance" live web
event on May 19, 2009.
“We
are happy to support ISPE's guidance on maintenance
management,” said
Jim Erickson, President of Blue Mountain Quality
Resources. “Maintenance management in the
life sciences is an area that has evolved a lot
in the last few years and a clear set of best practices
to help make sense of those changes will be very
valuable.”
For
more information about the web event announcing
the new guide, visit www.ispe.org.
Blue
Mountain Quality Resources Announces that Cepheid
has Selected Blue Mountain Regulatory Asset Manager
April
28,
2009 - Blue Mountain Quality Resources (State College,
PA) announced today that Cepheid has chosen Blue
Mountain Regulatory Asset Manager for use in their
manufacturing facilities.
“By bringing together calibration and maintenance
management into a single platform, Blue Mountain
Regulatory Asset Manager will allow us to maintain
the high-quality of our equipment process and procedure
control,” said Humberto Reyes, Cepheid’s
Chief Operating Officer. “This will enhance
collaboration and coordination of activity across
departments.”
Cepheid will use Blue Mountain Regulatory Asset
Manager to manage, document and improve calibration,
maintenance, and validation department operations.
About Cepheid
Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif.,
is a molecular diagnostics company that develops,
manufactures, and markets fully-integrated systems
and tests for genetic analysis in the clinical, industrial
and biothreat markets. The company’s systems
enable rapid, sophisticated genetic testing for organisms
and genetic-based diseases by automating otherwise
complex manual laboratory procedures. The company’s
easy-to-use systems integrate a number of complicated
and time-intensive steps, including sample preparation,
DNA amplification and detection, which enable the
analysis of complex biological samples in its proprietary
test cartridges. Through its strong molecular biology
capabilities, the company is focusing on those applications
where rapid molecular testing is particularly important,
such as identifying infectious disease and cancer
in the clinical market; food, agricultural, and environmental
testing in the industrial market; and identifying
bio-terrorism agents in the biothreat market. See www.cepheid.com for more information.
Alexion
Pharmaceuticals Chooses Blue Mountain Regulatory
Asset Manager® for Best-in-class Calibration Management
Integrated with SAP®
October
28, 2008 - Blue Mountain Quality Resources, Inc. (State
College, PA) announced today that Alexion Pharmaceuticals
has chosen Blue Mountain Regulatory Asset Manager®
to satisfy their immediate and long-term calibration
management needs as part of their enterprise-wide
SAP® implementation.
“Alexion
is committed to high standards for quality and productivity
in its manufacturing facilities and other operations,”
explains Jim Bilotta, CIO of Alexion. “We depend
on Blue Mountain to provide best-in-class applications,
including a calibration-management solution designed
for life sciences, to help us meet regulatory requirements
and our own quality objectives.”
Companies
use Blue Mountain’s integration tools between
Blue Mountain Regulatory Asset Manager and SAP. This
integration means that metrologists using Blue Mountain
Regulatory Asset Manager to manage their calibrations
can access asset information stored in SAP. At the
same time, information about calibration work orders
can be viewed from within SAP.
About
Alexion Pharmaceuticals
Alexion Pharmaceuticals, Inc., established in 1992,
is engaged in discovering, developing and delivering
new medicines for patients with severe diseases, including
rare disorders. Alexion’s first product, Soliris®
is a first-in-class complement inhibitor (a drug that
selectively targets the immune system). Soliris®,
a humanized monoclonal antibody, is approved in the
U.S. and Europe as a treatment for paroxysmal nocturnal
hemoglobinuria (PNH), a rare, debilitating and life-threatening
blood disease. The company is exploring the use of
Soliris® as a treatment for patients with other
rare and severe diseases, and is also developing its
ALXN6000 monoclonal antibody as a treatment for patients
with chronic lymphocytic leukemia.
More
information about Blue Mountain integration with SAP
New
Functionality in Blue Mountain Regulatory Asset Manager
Revolutionizes Impact Assessments and Streamlines
Resource Planning
April
21, 2008 - Blue Mountain Quality Resources announced
today a new release of its Blue Mountain Regulatory
Asset Manager software. The new release of the comprehensive
browser-based application designed to harmonize maintenance,
calibration and validation offers enhancements to
existing functionality and additional functional areas
of significant value to quality organizations, asset
end-users, and engineering management.
“With
this new release, Blue Mountain Regulatory Asset Manager
gives customers very strong and compelling answers
to inspectors trained in the Quality Systems Inspection
Technique” explains Jim Erickson, President
of Blue Mountain Quality Resources. “The software
now goes further to not only answer questions about
ensuring and documenting scheduled activity but also
how impact assessments and remediation is handled
when issues arise.”
New
process, lot and test management functionality within
Blue Mountain Regulatory Asset Manager now allows
companies to gain more control over manufacturing
and quality control processes and quickly discover
the impact of out of specification assets on production
and other operations. Quality organizations will be
able to immediately determine where one or more assets
was used within production batches or assay tests
in order to take quick and effective action to remediate
an issue. This functionality will drastically reduce
the time and produce more complete results than the
traditional impact assessments with data mining from
paper batch records and test methods, where inadvertent
omission of processes affected by an anomalous asset
is a justifiable concern.
Blue
Mountain Regulatory Asset Manager is easily configured
to match a company’s procedures for process
validation. To facilitate review, required information
about the process is collected and available in a
single location. Any trial runs of the process can
be scheduled and managed, including the collection
of tests that are performed on the trial runs. These
details include a complete list of assets used during
the trial lots and for any tests performed on those
lots.
Once
the process has been validated, it can be used for
production batches. Information about the approved
process, in addition to details specific to that batch
are available within the lot record used during the
course of producing that lot. Assay tests performed
on a lot, whether produced internally or not, can
be managed and tracked within Blue Mountain Regulatory
Asset Manager.
When
a lot or test is started, Blue Mountain Regulatory
Asset Manager automatically reviews all the assets
involved and advises the user which of those assets
will come due for calibration, maintenance or requalification
while that batch is running. Assets that are past
due for any of these scheduled events trigger a warning
to the user. The software then conforms to company
procedures on whether the user can proceed with the
process with the set of assets or force them to either
ensure the actions are performed before production
begins or take appropriate steps to find substitutes
for those particular assets.
In
addition to new process management features, the new
release of Blue Mountain Regulatory Asset Manager
also offers expanded resource planning features that
allow managers to forecast part and labor requirements
by week or by month up to 1 year into the future.
Having this information available within the application
streamlines planning and decision-making to optimize
parts inventory and make the most of limited human
resources.
An
electronic log book has been added for assets that
allowing for electronic data entry and review of traditional
logbook data under the auspices of user-configurable
functionality and electronic signature rules. Data
entry by equipment end-users and technical staff may
be reviewed remotely by designated personnel. The
traditional tasks of issuance and reconciliation of
paper logbooks is replaced by electronic records that
are easy to access and review.
Blue
Mountain Quality Resources Announces "Powered
by SAP NetWeaver®" Status for its Calibration
Management Solution
March
31, 2008 - Blue Mountain Quality Resources, Inc. announced
today that its Calibration Manager® solution version
4 has achieved “Powered by SAP NetWeaver®” status.
The certification will streamline integrations of
the life science’s industry standard calibration management
system with the SAP NetWeaver platform for seamless
information sharing across departments, elimination
of redundant data entry and to facilitate collaboration.
The
SAP Integration and Certification Center has certified
that Calibration Manager 4 properly integrates with
the SAP NetWeaver Exchange Infrastructure (SAP NetWeaver
XI) component of SAP NetWeaver to exchange critical
data with instances of the SAP Business Suite family
of applications. Blue Mountain has also demonstrated
that Calibration Manager integrates successfully with
the SAP NetWeaver Portal Release 6.0.
“The
life science industries have rigorous calibration
management requirements motivated by compliance, quality
and productivity pressures” explains Jim Erickson,
President of Blue Mountain Quality Resources. “The
certified integration means that customers using Calibration
Manager with SAP NetWeaver now have an integrated
solution throughout the organization without compromising
calibration.”
Integration
of Calibration Manager with the SAP NetWeaver platform
provides Blue Mountain’s best-in-class calibration
features (measurement data collection, reverse traceability,
instrument-centric management, etc.) with the maintenance
and enterprise management capabilities of SAP solutions.
This integration reduces redundancies, improves productivity
and provides better information for decision making
throughout the organization.
The
integration of Calibration Manager with SAP NetWeaver
follows a proven methodology developed to meet the
rigorous quality requirements of regulated life science
companies. Taking advantage of the SAP NetWeaver platform,
which unifies integration technologies into a single
platform to reduce the costs and need for custom integration,
information from and to the Calibration Manager database
in handled through a tested API (Application Programming
Interface). The distributed n-tier architecture of
Calibration Manager means that this regular sharing
of information does not impact the users of the system.
For
life science companies that will require the integration
to be validated before it can be put into use, the
completed integration will include appropriate IQ
and OQ validation scripts specific to their particular
solution. Assistance running these scripts, in addition
to PQ script generation and execution are also available.
Marcus
McNeely elected the Chairman for the Healthcare Metrology
Subcommittee of NCSL
Blue
Mountain Quality Resources is pleased to announce
that Marcus McNeely, a Project Manager at Blue Mountain,
has been elected the Chairman for the Healthcare Metrology
Subcommittee of NCSL. During his tenure, his responsibilities
will include defining the charter and long-term goals,
revising RP6, developing liaisons with other professional
organizations and reporting committee information
back to NCSLI.
Marcus McNeely has been in the field of Biotech and
Pharmaceutical metrology and validation for over fourteen
years. He has managed GMP/GLP/GSP biotech calibration
programs in both manufacturing and laboratory environments,
in addition to involvement in various biopharmaceutical
quality programs. He has also been responsible for
GMP, calibration and systems training for large groups
and individuals. Marcus holds a degree in electronics
engineering technology.
As Project Manager at Blue Mountain Quality Resources,
Marcus consults with biotech, pharmaceutical, and
medical device companies on best practices in every
step in establishing, managing, and maintaining a
calibration program.
Blue
Mountain Quality Resources Inc. Named Outstanding
Technology Company of the Year
Blue
Mountain Quality Resources was named Outstanding Technology
Company of the Year by the Chamber of Business &
Industry of Centre County. This award is given to
one company per year in the Centre County region of
Pennsylvania and is voted upon by fellow peers.
“This is a true honor and is a special recognition
to the company’s development and professional
service departments,” said James Erickson, President
of Blue Mountain. “Their innovative designs,
services and use of technology have established an
excellent reputation for Blue Mountain.”
For
over 15 years, Blue Mountain Quality Resources has
been developing and providing technologically-advanced
software solutions to the life science industry, including
the life science industries’ best-in-class calibration
management solution, Calibration Manager® with
over 1200 implementations worldwide.
In
2006, Blue Mountain Quality Resources took a bold
step by introducing a new product, Blue Mountain Regulatory
Asset Manager and creating a new class of software
for the life science industries. Anticipating industry
trends, Blue Mountain began development on this product
several years ago and can now offer a unique solution
to global, Fortune 500 companies looking to simplify
software systems.
Blue
Mountain is a leader in the asset management and life
science communities, with its employees speaking regularly
at industry events and conferences and offering industry
training, white papers and webinars.
For
additional information, contact Blue Mountain Quality
Resources, Inc. at 800-982-2388, 814-234-2417 or bluemountain@coolblue.com.
Blue
Mountain Quality Resources launches fall webinar
series for Blue Mountain Regulatory Asset Manager
Blue
Mountain Quality Resources has launched a series of
webinars for their new software solution, Blue Mountain
Regulatory Asset Manager. The hour-long webinars included
in this regular series are an overview, the calibration
benefits, details on the maintenance functionality,
and the validation management capability of this solution
for life science companies. Check www.coolblue.com/webinars
regularly for the latest times and dates available
for each webinar and to register.
Blue Mountain Regulatory Asset Manager is a comprehensive
integrated browser-based solution designed to enable
the collaboration of maintenance, calibration and
validation personnel. Such collaboration allows all
asset owners, technicians and quality managers to
work together to maintain assets in a controlled and
validated state. At the same time, the software reflects
the reality that calibration, maintenance and quality
personnel each have their own unique requirements
and ways of working with assets. Therefore, no group
needs to compromise on its own productivity.
White
Paper from Blue Mountain Quality Resources Discusses
the Latest Trends in Regulatory Asset Management
Blue
Mountain Quality Resources discusses the latest regulatory
asset management trends in their white paper, “Regulatory
Asset Management: Harmonizing Calibration, Maintenance
and Validation.” This paper focuses on the driving
forces of and solutions for integrating the calibration
and maintenance management of assets into a single
system to facilitate a collaborative approach to maintaining
the validated state.
The
white paper can be downloaded at www.coolblue.com/Assets/whitepapers_articles.htm.
Blue
Mountain Quality Resources Inc. Announces Blue Mountain
Regulatory Asset Manager, a new software product for
maintenance, calibration and validation management
June
28, 2006 - Blue Mountain Quality Resources today introduced
their newest software solution, Blue Mountain Regulatory
Asset Manager™, specifically designed to meet
the regulatory and productivity requirements of life
science companies. Blue Mountain Regulatory Asset
Manager is a comprehensive integrated browser-based
solution designed to enable the collaboration of maintenance,
calibration and validation personnel. Such collaboration
allows all asset owners, technicians and quality managers
to work together to maintain assets in a controlled
and validated state. At the same time, the software
reflects the reality that calibration, maintenance
and quality personnel each have their own unique requirements
and ways of working with assets. Therefore, no group
needs to compromise on its own productivity.
“Regulatory and business pressures at life science
companies have been driving a harmonization between
systems that manage calibration and maintenance, in
order to keep better control over the validated state
of assets and process,” explains James Erickson,
President of Blue Mountain Quality Resources. “However
earlier solutions, not being designed for this purpose,
have come up short on both meeting the individual
departmental requirements and providing full collaborative
benefits.”
Blue
Mountain Regulatory Asset Manager satisfies the strict
regulatory requirements of life science companies
not as an add-on module, but as an integral part of
the application. Tight integration with the entire
application means that changes to any record type
are documented and controlled, from asset and event
records to inventory and measurement data templates.
Records, including standards and event templates,
must pass their appropriate approval process and be
in an “approved” state before they are
available for use by other records. The ability to
build business rules into the approval process improves
compliance while minimizing the impact it can have
on overall productivity and efficiency.
At the core of Blue Mountain Regulatory Asset Manager
are its integral features to manage the validated
state of assets. That centralization of validation
streamlines the flow of information and approvals
throughout an asset’s life cycle. Features include
managing and documenting all activity, configuring
approval routes, and securing links to outside documents.
Additionally, for calibration professionals, the software
offers an instrument-centric approach with advanced
measurement data collection and standards management.
For maintenance professionals, it features a complete
work request and work order system, like-for-like
inventory management, and key performance indicators.
Blue
Mountain Regulatory Asset Manager is built on a Microsoft.NET
architecture with a web service architecture that
offers all the benefits of a browser-based, zero-client
application, including simpler system validation and
easy integration with other software packages such
as ERP and document management. The Enterprise version
of Blue Mountain Regulatory Asset Manager allows for
the deployment of the application at multiple sites
which drastically lowers total implementation and
validation costs.
About
Blue Mountain Quality Resources, Inc.
With over 15 years of experience in FDA-regulated
and ISO-compliant markets, Blue Mountain Quality Resources
has over 1000 validated software implementations.
The company offers a complete solution from set-up
and installation to training and validation for each
product. Whether an organization needs a single-user
implementation for a single department or a global,
multi-site turnkey package, Blue Mountain Quality
Resources offers complete regulatory asset management
solutions.
For
additional information about Blue Mountain Regulatory
Asset Manager and to register for upcoming product
webinars visit www.coolblue.com, or contact Blue Mountain
Quality Resources, Inc. at 800-982-2388, 814-234-2417
or ram@coolblue.com.
