Achieve control over the validated state
Controlling the validated state of assets and processes can be a time consuming endeavor at some organizations, and hit or miss at others. Calibration, maintenance and quality personnel each play a role in this process and the best results are achieved when they are able to share information and work together seamlessly.

Validation activity for assets and processes is managed through Blue Mountain Regulatory Asset Manager. Initial, periodic and ad-hoc qualification events are scheduled and documented through the same software used to document and schedule calibration and maintenance activity. Validation activity is managed through its own unique record types to meet its own unique requirements. Validation documentation, including controlled validation protocol documents, can be accessed directly from within any WebDAV-compliant document management system or file server.

Blue Mountain Regulatory Asset Manager further allows quality personnel to achieve control over the validated state. With calibration, maintenance and validation personnel all using a single system to manage assets, the software can be configured to send automatic notifications across groups to notify when an activity has been scheduled or completed. With this notification any follow up activity that may be required can be scheduled quickly and efficiently and quality personnel are aware immediately when activity that threatens the validated state has occurred.

Blue Mountain Regulatory Asset Manager also features configurable electronic approval routing to improve work flow and processing of approval on changes. Data entry on the record can be restricted based on the current status of the record and prevented from being used if not an “approved” state. With strict control of records and audit trail on activity throughout the application, all aspects of the validated state are controlled, even down to storing procedures and results from qualification activity.

When questions arise, Blue Mountain Regulatory Asset Manager provides the tools to streamline impact assessments and remediation. Quality personnel can trace back where spare parts, calibration standards and other assets were used in work on assets, locations, batches or tests to quickly and confidently determine where remediation is required. This not only provides incredible cost savings when an impact assessment is required, but also provides a solid answer to the FDA's expectations for life science companies to have comprehensive procedures to respond to problems should they ever arise.

Simplify your next Quality Systems Inspection
The FDA and other similar regulatory agencies have started to take a top-down, system-based approach to inspections and audits called the Quality Systems Inspection Technique (QSIT). Instead of looking at the end results of processes for small abnormalities, they are focusing instead on the elements of the total quality system that are most important to meeting requirements.

Reducing the number of systems being used to manage similar activity can greatly simplify future audits, with fewer systems to explain and have inspected. ”Facility and Equipment”, grouped by the FDA into a one of the seven subsystems that make up a complete quality system, is one area that can now be brought into a single system.

In the past, bringing such disparate disciplines as calibration and maintenance together under a single system has been complicated by that fact that each group has their own way of working with assets and data entry requirements. By allowing each group to work their way within a single system, Blue Mountain Regulatory Asset Manager offers a single comprehensive integration software solution to manage your facilities and equipment. The software allows you to track the full life cycle of equipment, from calibration and maintenance to validation.

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