1. Implementing a Calibration Management System Cory Otto Principal Metrology Engineer, Boston Scientific 10 October 2012

2. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Agenda  Discuss establishing the need for a new calibration management system  Review selection process  Provide high level overview of implementation activities  Discuss lessons learned  Answer questions 2

3. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Establishing Need 3

4. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Establishing Need  FDA Corporate Warning Letter  Legacy Software Remediation (LSR) efforts  Calibration management system (CMS) determined to be in scope  Had not been previously validated  CMS was assessed  Issues noted -Security -Operations and maintenance -Producibility -Audit trails -Electronic records/electronic signatures 4 In the end, it was determined that it would be non-value added to bring CMS to a substantially validated state

5. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process 5

6. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  Reviewed CMS options  Established initial requirements  Weighted options vs. initial requirements 6 Option 1 Option 2 Option 3 Old CMS

7. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  Meeting #1 with senior management (January 2009) –Explained need –Reviewed alternatives –Proposed Option 1 –Response: Investigate feasibility of Option 3 7 Option 1 Option 2 Option 3 Old CMS

8. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  Beware the 8

9. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  Meeting #2 with senior management (April 2009) –Explained why Option 3 would not meet requirements –Proposed Option 1 Explained how it meets requirements and has exciting Metrology bells and whistles –Senior management response: What are the other sites using? 9

10. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  Be prepared!  Know what is important to your audience 10

11. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  Meeting #3 with senior management (June 2009) –Explained what each site was using as a CMS Many sites were using CalMan v4.x (the predecessor to BMRAM) –Proposed Option 2 (BMRAM) Explained how it meets requirements –Senior management response: Nothing! 11

12. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  You need an advocate 12

13. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  Meeting #4 with senior management (August 2009) –Explained need –Reviewed site CMS usage –Discussed financial information –Proposed BMRAM Explained how it meets requirements –Requested approval –Senior management response: Nothing! 13

14. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  Have patience 14

15. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Selection Process  November 2009 –Received senior management permission to move forward with the purchase and implementation of BMRAM –Added to Corporate Information Systems meeting agenda to request IS Project Manager  December 2009 –Corporate Information Systems meeting delayed multiple times –Maple Grove Metrology management decision made to move forward without IS Project Manager 15

16. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Implementation 16

17. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 17 Establish a Team  Core team  Project lead  Metrology management  Metrology Engineer  Technical Writer  Software Quality Engineer  Blue Mountain Project Manager  Extended team members  Previous CMS Administrators  Customers  Focus panel from other BSC sites

18. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  If time allows, have a representative from each role on your core team 18

19. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 19 Develop a Plan  Developed Microsoft Project plan  Feeders  Blue Mountain’s input/internal project management process  Boston Scientific’s validation requirements  Personnel schedules  Deliverables  LSR timeline  Vetting process  Reviewed by  Metrology management  Software Quality management  Senior management  Corporate IS management

20. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Lessons Learned  Plan the work and work the plan 20

21. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 21 Learn the Language  Underwent validation training  Majority of core team had never validated software before  Wanted to select a validation method that would allow other Boston Scientific sites the opportunity to leverage validation in the future  Needed to understand deliverables

22. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 22 Validation Deliverables  Concept document –Why are you validating this software?  Project assessment –Series of generic questions –Intended use based rating system to determine the level of validation required  Hazards and risk analysis –Early understanding of potential hurdles on the horizon

23. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 23 Validation Deliverables  Requirements –What do you require of the software? –Feeders End users Department workflows Software Quality requirements FDA/CFR requirements  Testing scripts –Plans –Scripts Installation qualifications (hardware and software) Operational qualifications Performance qualifications –Reports  Design –Hardware and software

24. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 24 Validation Deliverables  Implementation plan  Business continuity plan  Production support plan In total, there were 50 documents created or updated as part of this project (totaling 79 revisions)

25. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Jan -Identified project team (Team Pinnacle) -Developed Project Plan May -Developed Test Plan -Migrated Data (1 of 3) June -Conducted IOQ testing July -Documented testing -Developed validation documents Dec -Go live! Feb -Developed BPR -Developed and purchased hardware architecture Mar -Documented requirements specification -Qualified hardware Apr -Completed GSM Planning phase -Conducted site assessment -Configured software Aug -Conducted PQ testing -Migrated data (2 of 3) Sep -Create WIs Oct -Train end users -Migrate data (3 of 3) Nov -Align system data -Complete validation docs Validation Deliverables

26. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 26 Lessons Learned  Keep everyone up to date and hold everyone accountable  Core team met weekly  Reviewed  Closed action items  Open action items  Current status  Path forward plan  Corporate IS meetings were monthly to quarterly  Senior management meetings were quarterly

27. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 27 Lessons Learned  Err on the side of over communication with your end users  Announcements  Seeking input  Training  Refresher training

28. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 28 Lessons Learned  Use as much time as possible to scrub your data  What good is a shiny new toy with garbage in it?

29. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 29 Lessons Learned  You need a strong partner

30. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally Questions? Cory Otto cory.otto@Bsci.com 30