Blue Mountain Quality Resources, Inc. Global Compliance and Standardization with an Enterprise CMS Jim Erickson, President Blue Mountain Quality Resources, Inc.

Blue Mountain Quality Resources, Inc. Overview The Changing Manufacturing Environment

Blue Mountain Quality Resources, Inc. Overview The Changing Manufacturing Environment Enterprise CMS Fundamentals

Blue Mountain Quality Resources, Inc. Overview The Changing Manufacturing Environment Enterprise CMS Fundamentals Selection Process

Blue Mountain Quality Resources, Inc. Overview The Changing Manufacturing Environment Enterprise CMS Fundamentals Selection Process Implementation Process

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Recession

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalization

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalizationConsolidation

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalizationConsolidation Cost Reductions

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalizationConsolidation Cost Reductions Increased Compliance

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Quality System Requirements

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Quality System Requirements –Cost Reduction

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Quality System Requirements –Cost Reduction –Measurable ROI

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Quality System Requirements –Cost Reduction –Measurable ROI –Simplified Deployment

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Quality System Requirements –Cost Reduction –Measurable ROI –Simplified Deployment –Meets Global Compliance Needs

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements - Basics

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements - Basics –Instrument Inventory

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements - Basics –Instrument Inventory –Scheduling

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements - Basics –Instrument Inventory –Scheduling –History – As Found/As Left Data

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements - Basics –Instrument Inventory –Scheduling –History – As Found/As Left Data –Standards Use and Traceability

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level –Multi-Site Enterprises

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level –Multi-Site Enterprises –Centralized Standards Laboratory

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level –Multi-Site Enterprises –Centralized Standards Laboratory –Multi-National Enterprise

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level –Multi-Site Enterprises –Centralized Standards Laboratory –Multi-National Enterprise –Site Specific Requirements

Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Calibration Management System Requirements – Enterprise Level –Multi-Site Enterprises –Centralized Standards Laboratory –Multi-National Enterprise –Site Specific Requirements –Global Compliance Standardization

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution A centrally hosted, highly distributed software application allowing centralized control with site flexibility.

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Management Basis

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Management Basis –Single – Standard Application

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Management Basis –Single – Standard Application –Implement Best Practices

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Management Basis –Single – Standard Application –Implement Best Practices –Centralized Control

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Management Basis –Single – Standard Application –Implement Best Practices –Centralized Control –Yet Regional Flexibility

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Technological Basis

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Technological Basis –Web Based Architecture

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Technological Basis –Web Based Architecture –Centralized IT Services

Blue Mountain Quality Resources, Inc. Enterprise CMS – A Solution Technological Basis –Web Based Architecture –Centralized IT Services –Proven Paradigm

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Basics

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Basics –Instrument Inventory –Scheduling –History – As Found/As Left Data –Standards Use and Traceability

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Enterprise Level

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Enterprise Level –Datasets for Each Location

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Enterprise Level –Datasets for Each Location –Flexibility in Customization

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Enterprise Level –Datasets for Each Location –Flexibility in Customization –Centralized Security

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Enterprise Level –Datasets for Each Location –Flexibility in Customization –Centralized Security –Centralized Reporting – Across the Enterprise

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Compliance Level

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Compliance Level –Measurement Uncertainty

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Compliance Level –Measurement Uncertainty –Technician Training

Blue Mountain Quality Resources, Inc. Enterprise CMS – Functionality Compliance Level –Measurement Uncertainty –Technician Training –Electronic Records – Electronic Signatures

Blue Mountain Quality Resources, Inc. Enterprise CMS – Architecture Web Based Architecture –n-Tier Design Database Level Middle Tier – Web Server Graphical User Interface

Blue Mountain Quality Resources, Inc. Enterprise CMS – Architecture “Stateless” Design –Superior to traditional Client/Server –Lowers Network Resources –Doesn’t Require Terminal Server or Citrix –Lessens Database Licensing

Blue Mountain Quality Resources, Inc. Enterprise CMS – Architecture

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance Flexibility at the Site Level

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance Flexibility at the Site Level Faster ROI

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance Flexibility at the Site Level Faster ROI Reduced Training Costs

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance Flexibility at the Site Level Faster ROI Reduced Training Costs Reduced Implementation Costs

Blue Mountain Quality Resources, Inc. Enterprise CMS – Benefits Implementation of Best Practices Centralized Control of Compliance Flexibility at the Site Level Faster ROI Reduced Training Costs Reduced Implementation Costs Reduced Validation Costs (FDA)

Blue Mountain Quality Resources, Inc. Selection Process Determine Group Members

Blue Mountain Quality Resources, Inc. Selection Process Determine Group Members Foster Teamwork

Blue Mountain Quality Resources, Inc. Selection Process Determine Group Members Foster Teamwork Determine Scope

Blue Mountain Quality Resources, Inc. Selection Process Determine Group Members Foster Teamwork Determine Scope Secure Senior Management Support

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line Request For Proposals

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line Request For Proposals Qualify Vendors and Applications

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line Request For Proposals Qualify Vendors and Applications Selection Matrix

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line Request For Proposals Qualify Vendors and Applications Selection Matrix Intangibles

Blue Mountain Quality Resources, Inc. Selection Process Develop User Requirements Specifications Vendor Research Budget Preparation Develop Time Line Request For Proposals Qualify Vendors and Applications Selection Matrix IntangiblesSelection

Blue Mountain Quality Resources, Inc. Implementation Process Develop Project Plan Install Configuration Prototype Configuration Training Develop Configuration Plan Data Migration Production Installation Validation (FDA) User Training “Live” Cut Over – First Group Roll Out Maintenance

Blue Mountain Quality Resources, Inc. Conclusion Productivity Gains Minimized Compliance Risk ROI