1. ROI Gains in Blue Mountain RAM Scott Fry, Director of Professional Services September 18, 2013

2. Overview  ROI gains in Blue Mountain RAM –Compliance gains –Efficiency gains

3. Investing in Blue Mountain BMRAM  Benefits –Compliance gains are great Regulatory –21 CFR Part 11, validated tracking, record retention –Efficiency gains are greater Efficiency gratifications –Enormous efficiency gains are very achievable and very measureable –How did you ever live without this?

4. Compliance Gains  Blue Mountain BMRAM –Commercial off the shelf application. –21 CFR Part 11, validated tracking, record retention –Options Template solution –Essential and Best Practices Custom configuration

5. Efficiency Gains with BMRAM Your efficiency gains with help pay for the initial investment

6. Efficiency Gains with BMRAM  Functional areas of efficiency gains –Production calibration –Production maintenance –Validation –Facilities –Quality Control

7. Efficiency Gains with BMRAM  Asset inductions  System integration  Equipment labeling  Out of Tolerance investigations  Work request tracking  Equipment check-in  Harmonized multisite implementations

8. Efficiency Gains with BMRAM  Workspaces  Paperless workflow  Standards traceability  Reporting

9. Efficiency Gains with BMRAM Management wants to see productivity gains and key performance indicators to improve downtime

10. Efficiency Gains with BMRAM  Pre-defined Business Rules –Can be automated Software is flexible for custom process flows Approval processes can mimic paper flows Alternate business flows for non-routine conditions. Takes longer in a paper-based system

11. Efficiency Gains with BMRAM  Electronic reviews –Reduces anomalies from paper based documentation –Provides pre-defined, uniform data entry template Forgot to sign, date errors, miscalculations, illegible entries –If a reviewer has 30 completed calibration forms, what percentage will have errors like these?

12. Efficiency Gains with BMRAM  Electronic retrieval / circulation –Saves time by instant notifications and access Time spent looking for calibration documents Don’t go paperless if you enjoy walking What happens when records are misfiled?

13. Efficiency Gains with BMRAM  KPI/Metrics –Retrieve specific data for performance, costs, data points and trending –Enhanced system use may warrant investigation into a higher degree of BI –Management dashboards  Blue Mountain BMRAM Integration –LIMS/MES –ERP/PM

14. Efficiency Gains with BMRAM More customers are investing in other features because they see firsthand the ROI

15. Efficiency Gains with BMRAM  Later this afternoon –Case Study: The Road to a Multi-Site Implementation and the ROI Gains –Continuing ROI Post Implementation