Blue Mountain Regulatory Asset Manager is a comprehensive, browser-based software solution designed to enable the collaboration of maintenance, calibration and validation personnel. This allows all asset owners, technicians and quality managers to work together to maintain assets in a controlled state. At the same time, the software reflects the reality that calibration, maintenance and quality personnel each have their unique requirements and ways of working with assets. Therefore, no group needs to compromise on productivity.
As an integrated solution, changes to any record type are documented and controlled. Records must pass through their appropriate approval process before they are available for use by other records, which improves compliance and productivity.
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Key Features
- Full work request and work order system for managing work for critical and non-critical (GMP and non-GMP) assets
- Integral like-for-like inventory management and automatic routing for electronic change control signatures
- Control over the validated state with management of qualification activities and regulation of activities
- Schedule calibration, maintenance and validation activity in unison to minimize downtime
- Configure automatic notifications across functions according to business process rules
- Eliminate multiple applications for managing separate engineering functions
- Fully 21 CFR Part 11 compliance electronic records features with advanced electronic signature routing, including configurable asset lifecycle states and approval routes
- GxP compliance includes best-in-class calibration functionality including sophisticated standards tracking, streamlined measurement data collection and complete notification system for failed calibrations and out of tolerance readings
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Target Business Size
- Mid-Size (100-999 employees)
- Large (1000+ employees)
- Small (<100 employees)
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Platform
- Microsoft Windows NT/2000/XP
- Microsoft Windows Server 2003
- Microsoft Windows XP/Vista
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Database
- Microsoft SQL Server
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CORE CAPABILITIES
- Cost of Quality
- Hazardous Material Reporting
- Inspection and Testing
- Laboratory Information Management
- Nonconformance and Corrective Action
- Product Handling and Servicing
- Quality Documentation
- Quality System Interfaces
- Statistical Analysis/Techniques
- CAD Visualization
- Computer Aided Engineering (CAE)
- Computer Aided Manufacturing (CAM)
- Computer Aided Process Planning (CAPP)
- Digital Design Management
- Document Management
- Engineering
- Engineering Change & Configuration Management
- Formulation
- Product Data Management
- Product Information Management
- Product Lifecycle Collaboration
- Product Variant Configuration
- Production & Event Simulation
- Project, Program & Portfolio Management
- Asset Management
- Materials Management
- Procurement
- Work Management
- Analytics
- Data Lifecycle Management
- Data Warehousing
- Integration
- Predictive Intelligence
- Process Modeling
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Industries
- Pharmaceuticals
- Medical Devices
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Countries
- Swaziland
- Mauritania
- Egypt
- Mongolia
- Suriname
- Bahrain
- Moldova
- Norway
- Niue
- Mauritius
- Albania
- Tunisia
- Kazakhstan
- San Marino
- Bahamas
- Mayotte
- USA
- Palau
- Vanuatu
- United Kingdom
- Tokelau
- Algeria
- French Polynesia
- Belize
- Somalia
- Grenada
- Croatia
- Turkmenistan
- Slovenia
- Cyprus
- Chile
- Papua new Guinea
- Aruba
- Gabon
- Thailand
- Georgia
- Guernsey
- Ethiopia
- Sri Lanka
- American Samoa
- Tajikistan
- Iceland
- Maldives
- Azerbaijan
- Bosnia
- Macau S.A.R.
- Cook Islands
- Laos
- Kyrgyzstan
- Belarus
- Spain
- Ukraine
- Faroe Islands
- Panama
- Cocos (Keeling) Islands
- Chad
- China
- French Guiana
- Liberia
- Anguilla
- Sierra Leone
- Kiribati
- United Arab Emirates
- Greenland
- New Zealand
- Virgin Islands (British)
- Trinidad and Tobago
- Pakistan
- Afghanistan
- Dominican Republic
- Libya
- Martinique
- Costa Rica
- Yugoslavia
- Djibouti
- Equatorial Guinea
- Madagascar
- Nicaragua
- Zimbabwe
- Congo
- Namibia
- Nauru
- Uganda
- El Salvador
- Micronesia
- Singapore
- Korea
- Bouvet Island
- Guyana
- Monaco
- South Africa
- East Timor
- Morocco
- Israel
- Lesotho
- Uzbekistan
- Brazil
- India
- Malawi
- Canada
- Eritrea
- Korea, North
- Yemen
- Guadeloupe
- Sudan
- Montserrat
- Peru
- Gambia
- Cameroon
- Poland
- Nepal
- Cambodia
- Dominica
- Lebanon
- Latvia
- Myanmar
- Nigeria
- Italy
- Samoa
- Zaire
- Cuba
- Cape Verde
- Turkey
- Mozambique
- Barbados
- Christmas Island
- Philippines
- Tuvalu
- Portugal
- Slovakia
- Saint Helena
- Fiji Islands
- West Indies
- Indonesian
- Antigua And Barbuda
- Guatemala
- Guinea
- Oman
- Seychelles
- Senegal
- Kuwait
- Honduras
- Venezuela
- Belgium
- Pitcairn Island
- Reunion
- Jamaica
- Solomon Islands
- Australia
- Bermuda
- Liechtenstein
- Netherlands
- France
- Rwanda
- Burkina Faso
- Iraq
- Burundi
- Marshall Islands
- Czech Republic
- Armenia
- Hungary
- Botswana
- Taiwan
- Greece
- Antarctica
- Jordan
- Saudi Arabia
- Benin
- Ecuador
- Bulgaria
- Iran
- Tanzania
- Mali
- Bolivia
- Comoros
- Vietnam
- Mexico
- Qatar
- Colombia
- West Africa
- Guinea-Bissau
- Togo
- Syria
- Brunei
- Luxembourg
- Norfolk Island
- Denmark
- Zambia
- New Caledonia
- Malta
- Hong Kong
- Saint Lucia
- Haiti
- Paraguay
- Switzerland
- Cayman Islands
- Niger
- Russia
- Kenya
- Austria
- Finland
- Isle of Man
- Gibraltar
- Bhutan
- Sweden
- Lithuanian
- Angola
- Andorra
- Germany
- Malaysia
- Ghana
- Ireland
- Argentina
- Romania
- Uruguay
- Japan
- Estonia
- Bangladesh
- Tonga
About Blue Mountain Quality Resources Inc.
Blue Mountain Quality Resources is the validated leader in regulatory asset management. Our products Blue Mountain Regulatory Asset Manager, an integrated, comprehensive software package for managing calibration, validation and maintenance, and Calibration Manager, best-in-class calibration management software, are designed to manage compliance and increase productivity, while lowering overall costs.
