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The Blue Mountain Quality Resources Newsletter keeps you up-to-date on developments with Blue Mountain Regulatory Asset Manager, as well as the trends in the industry. The newsletter includes:

• Blue Mountain Regulatory Asset Manager news
• Upcoming product training opportunities
• Access to technical white papers
• Information on and links to calibration resources
• Blue Mountain Quality Resources press releases
• Editorial from Director of Marketing

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March Editorial

Assets at the center of it all

March 2, 2010

New guidance in the life science industries is putting increased emphasis on understanding and controlling processes as a means to ensure quality. This new emphasis is made apparent by the Quality Systems approach, in which FDA inspectors are looking for systems in place to ensure consistent output from production. They expect subject matter experts to understand the sources of variation and take actions to minimize variations, of course thoroughly documenting all reasoning and actions taken along the way.

Is it just me or doesn't that put assets squarely in the middle of things when it comes to cGMP compliance? In each of these areas, assets play a key role:

• One of the greatest areas of variation in production comes from the working condition of assets (equipment, instruments, etc.). To control that variation, processes and systems are expected to ensure that required maintenance, calibration and, in general, the management of the validated state occur on those assets.
• When problems do arise, generally asset information forms the foundation for both an impact assessment and FMEA.
• Once the problem is discovered, its resolution usually revolves around changes to assets or how assets are managed.

Since ensuring consistent output, diagnosing problems and developing resolutions to problems all involve assets, doesn't it make sense to invest in an asset management system designed to meet these challenges?

Chances are that if you're reading this you agree with me and understand the importance of best-in-class asset management designed for the unique landscape that life science companies face. Hopefully the new language and guidance from regulatory agencies add weight and maybe even a sense of urgency to your argument. Please let us know how we can help in your effort to improve asset management.

Bryce Johannes
Director of Marketing
Blue Mountain Quality Resources, Inc.

P.S. Uptime Magazine recently published a Blue Mountain paper on the decisions around specifically calibration management and ERP systems (read article here), when and how to integrate versus using separate systems, etc. If this topic interests you, you'll also want to check out the first webinar mentioned below.