The software’s unique database design offers incredible flexibility to meet each company’s and each department’s unique needs. In addition to the built-in features for calibration, maintenance and validation, the database and user-interface design offers a wide collection of user-defined fields, which means that each department can track exactly the information they need. This flexibility means that the software can also be used for related applications such as IT asset management and environmental monitoring management.

Blue Mountain Regulatory Asset Manager's service-oriented architecture makes integration with other systems, including ERP and document management, easier and less costly. By separating activity performed by the application into discrete services the system can accept information and instructions from other applications or share information with other applications without cumbersome and intrusive interaction directly with the database fields.

The Enterprise version of Blue Mountain Regulatory Asset Manager allows for the deployment of the application at multiple sites. This broader deployment of the application drastically lowers total implementation and validation costs. The Enterprise version offers additional features to enhance productivity, compliance and flexibility, with the ability to customize settings, fields, time zone, language and cultural settings by site.

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Reduce total time and costs to implement and validate a new system
When using internal or inexperienced resources, implementation and validation of new asset management systems can be a long and painful process. It can disturb your ongoing operations and delay the final implementation of the system with no assurances that the validation will be performed to regulatory requirements. For this reason, and to reduce the risk of compliance failures or audit issues (including the dreaded 483), many of our customers have turned to us for tools and assistance during validation.

Validation of a GxP software database is generally comprised of three steps - defining system requirements (URS - User Requirement Statements) matched to the software's functional requirement (FR), qualifying the software vendor, and performing the IQ, OQ, and PQ of the software. Blue Mountain Quality Resources has the experience and resources to help organizations easily and efficiently satisfy each of these steps.

Many customers take advantage of our Validation Services to manage the complete validation. By outsourcing this activity to someone with substantial experience, companies can drastically reduce the total validation time. Companies validating on their own can experience IQ and OQ completion times of months, sometimes much longer if any unanticipated difficulties arise.

For new facilities or when under pressure to comply with regulatory “recommendations”, it is often necessary to get a new calibration, maintenance, or validation department up and running on a tight schedule. Sometimes short timeframes are further dictated by a desire to harvest the return on investment from more sophisticated software package sooner.

Blue Mountain Quality Resources has the experience and resources to get you up, validated, and running quickly, enjoying the maximum benefits of the new system. The experience of our technicians means that the implementation is done efficiently. And the depth of our resources means that certain steps in the implementation and validation process can be performed in parallel, further compressing the time required to complete implementation.

We can manage your complete implementation, right through the validation, or help you overcome specific bottlenecks in your implementation. Our implementation solutions give you the flexibility and the resources to put you on the fast track.

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Benefit from industry best practices and expertise
We have been working with clients in regulated life science industries to improve productivity and compliance since 1992. We employ service professionals and trainers with direct asset management experience in those industries. This combination provides us with unique access to industry best practices and expertise. We share this industry best practice with every implementation and optimization of Blue Mountain Regulatory Asset Manager we’re involved with, offering timely advice on how best to make use of the applications within the bigger picture of a facility or organization. However, we not only help companies make the most of these systems, but also offer assistance in establishing SOPs throughout the different disciplines of asset management.

Blue Mountain Quality Resources also offers a regular and growing series of training sessions on industry topics, from introductory courses on calibration, maintenance and validation for individuals new to those fields within life sciences to courses on larger themes such as the latest trends and best practices for managing all the departments and interests that go into asset management.

Reduce total costs with multiple-site implementations
The FDA is increasingly requiring consistency across operating divisions of corporations. For example, manufacturing and processes that take place at one site need to be similar to those in other locations. A single installation over multiple sites will also reduce the cost in application licensing fees, corporate IT resources, validation, training and internal auditing.

The Enterprise version of Blue Mountain Regulatory Asset Manager makes tracking calibration, maintenance and validation at multiple sites a reality. The software is built on a Microsoft .NET architecture that offers all the benefits of a browser-based, zero-client application, including easy deployment to multiple sites.

Blue Mountain Regulatory Asset Manager offers unique flexibility within the application allowing for each site, even areas with sites, to set up the application to fit distinct requirements. You can customize fields, preferences, rights, time zone and cultural settings by site.

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Share information automatically with other systems
To run your business, you rely on a broad range of different applications. Each of those applications requires its own database and handles data uniquely and therefore usually requires some data to be entered multiple times. To avoid this duplication of effort, many organizations have wished that the applications could share information back and forth automatically.

Blue Mountain Quality Resources can develop and has developed custom Blue Mountain Regulatory Asset Manager and Calibration Manager integration with other applications to automate the transfer of information with other applications, including ERP (including SAP), LIMS, and many others. The productivity and compliance gains from this automation can have a significant impact on your bottom line and improve regulatory requirements set down by the FDA and Sarbanes-Oxley.

Depending on the exact needs, Blue Mountain Quality Resources can create integration that simply passes information to another application on a regular schedule or as sophisticated as constant updates between application in “real time”. The web service architecture of Blue Mountain Regulatory Asset Manager simplifies integration, making simple integrations to specific document management systems or report builders very practical and affordable.

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