Press Release Summary:
Designed to harmonize maintenance, calibration, and validation, browser-based Blue Mountain Regulatory Asset Manager includes process, lot, and test management functionality, which allows companies to gain control over manufacturing and quality control processes and discover impact of out-of-specification assets on production and other operations. Resource planning features allow managers to forecast part and labor requirements by week or by month up to 1 year into future.
Original Press Release:
New Functionality in Blue Mountain Regulatory Asset Manager Revolutionizes Impact Assessments and Streamlines Resource Planning
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.
About Blue Mountain Quality Resources
Blue Mountain Quality Resources is the validated leader in regulatory asset management. Blue Mountain Regulatory Asset Manager, the company's flagship software product, is a comprehensive integrated browser-based solution designed to enable the collaboration of maintenance, calibration and quality personnel to manage the validated state of assets and processes. With 15 years of experience in FDA-regulated and ISO-compliant markets and over 1000 life science implementations, Blue Mountain offers a complete solution from set-up and installation to training and validation.
For more information about Blue Mountain Regulatory Asset Manager or to register for upcoming webinars and web demos visit www.coolblue.com or contact Blue Mountain Quality Resources, Inc. at 800-982-2388 or firstname.lastname@example.org.