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.

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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.

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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, 2008 - 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.