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Blue Mountain Quality Resources announced today they are hosting a new web event for the Life Science industry, “Part 11 Electronic Record and Signature Compliance with Blue Mountain Regulatory Asset Manager” on October 26, 2010 at 2pm EDT.

Blue Mountain Quality Resources is a leader in the implementation of Part 11 Electronic Records and Electronic Signatures. The company’s Best in Class calibration and maintenance software solution, Blue Mountain Regulatory Asset Manager, has tightly integrated Part 11 functionality which can help ensure compliance the FDA is requiring while maximizing productivity from a paperless system.

Recently, Part 11 compliance has taken on renewed significance in FDA inspections. This web event will present an overview of the current 21 CFR Part 11 Rule, including:

  • A brief review of the actual rule
  • The FDA’s renewed priority on inspecting to the Rule
  • The FDA’s Guidance Documents for the Rule
  • Industry’s GAMP 5 interpretation

The second portion of the web event is a demo showcasing Blue Mountain Regulatory Asset Manager’s key functionality for enabling 21 CFR Part 11 compliance, including:

  • Managing Work Flow with Part 11 compliant Work Rules
  • System and Record Change Control
  • Audit Trails
  • Validation & System Level IT Compliance

An organization can benefit greatly by having the latest Part 11 information and training. In addition, participants will learn how Blue Mountain Regulatory Asset Manager can meet those Part 11 requirements for overall efficiency. Plus, following the web event, a training certificate will be available.