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

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

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

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

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

6. Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment Recession

7. Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalization

8. Blue Mountain Quality Resources, Inc. Changing Manufacturing Environment RecessionGlobalizationConsolidation

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

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

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

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

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

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

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

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

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

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

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

20. 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

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

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

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

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

25. 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

26. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

49. 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

50. Blue Mountain Quality Resources, Inc. Enterprise CMS – Architecture

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

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

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

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

55. 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

56. 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

57. 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)

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

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

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

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

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

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

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

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

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

67. 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

68. 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

69. 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

70. 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

71. 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

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