Implementing a Calibration Management System

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

2. 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

3. Establishing Need

4. 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 In the end, it was determined that it would be non-value added to bring CMS to a substantially validated state

5. Selection Process

6. Selection Process • Reviewed CMS options • Established initial requirements • Weighted options vs. initial requirements Option 1 Option 2 Option 3 Old CMS

7. Selection Process • Meeting #1 with senior management (January 2009) • Explained need • Reviewed alternatives • Proposed Option 1 • Response: • Investigate feasibility of Option 3 Option 3 Option 2 Option 1 Old CMS

8. Lessons Learned • Beware the

9. 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?

10. Lessons Learned • Be prepared! • Know what is important to your audience

11. 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!

12. Lessons Learned • You need an advocate

13. 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!

14. Lessons Learned • Have patience

15. 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

16. Implementation

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. Lessons Learned • If time allows, have a representative from each role on your core team

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. Lessons Learned • Plan the work and work the plan

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. 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. 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. 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. Validation Deliverables Nov -Align system data -Complete validation docs July -Documented testing -Developed validation documents Aug -Conducted PQ testing -Migrated data (2 of 3) Dec -Go live! June -Conducted IOQ testing Sep -Create WIs May -Developed Test Plan -Migrated Data (1 of 3) Oct -Train end users -Migrate data (3 of 3) Apr -Completed GSM Planning phase -Conducted site assessment -Configured software Mar -Documented requirements specification -Qualified hardware Feb -Developed BPR -Developed and purchased hardware architecture Jan -Identified project team (Team Pinnacle) -Developed Project Plan

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. Lessons Learned • Err on the side of over communication with your end users • Announcements • Seeking input • Training • Refresher training

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. Lessons Learned • You need a strong partner

30. Questions? Cory Otto cory.otto@Bsci.com