1. Smart Meter Verification and FDA 21 CFR part 11 Tom O’Banion Director of Industry Differentiation

2. AgendaAgenda Review of Terms Third Party Agency Work –Overall update –FDA AMS Snap-on and ProLink advantages –AMS Screen shots

3. Terminology: Calibration, Validation, and Verification Definition of terms –Calibration: Establishing the relationship between flow and signal produced by sensor. Processes –Validation: Confirming flow performance by comparing a primary flow standard to sensor. In F&B, Pharma, and LifeScience, Processes are also often validated –Verification: Establishing confidence in performance by analysis of secondary variables associated with flow Frequently these terms are used interchangeably Many times calibration or validation is done when only verification is needed Micro Motion measures tube stiffness to verify complete performance

4. AgencyApplicationSMV Status AER (Alberta)HC fiscal transfer Recognized US EPAGreenHouse Gas (40 CFR part 98) Recognized US EPAAcid Rain (40 CFR part 75) (EPA will use AGA docs, FY15) ISO 9001Various Recognized IEC (for SIS)Safety Instrumented Systems Recognized via Proof Test AGA -11 / API MPMS Ch 14.9 Natural Gas fiscal transfer Recognized Nmi (NEL and Pigsar test labs) Test data used for other Agencies Q2 2015 Russia Various metrologyEst Sep/Oct 2015 NIM (China) CT, Various JJG1038-2008 rev?Staring April 2014 FDA & TTB Meter validation SMV complies w/ proper recordkeeping API 20.2 Allocation / royalty meters Ballot Feb 2015, est Sep 2015 release API 5.6 Fiscal Transfer Liquid HCTBD 2016 NIST Liquid chemical fiscal transferNot yet active

5. 7.6 Control of monitoring and measuring equipment The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4); b) be adjusted or re-adjusted as necessary; c) have identification in order to determine its calibration status; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). ISO 9001 (Often used in F&B) ISO 9001 (Often used in F&B)

6. FDA FDA Official MMI letter stating SMV is “manufacturer recommended best practice” Part of Rosemount Hygienic initiative FAQ developed

7. FDA FAQ for Sales FDA FAQ for Sales Document # GI 002000 Rev A

8. FAQ Excerpts Add SMV to SOP Run SMV once per quarter and file report Share in conjunction with SMV and Zero Verification Tool videos Ask probing questions about current work practices, cost of calibration, etc. Meters with 800 ECP can be easily upgraded to SMV in the field When quoting a project, use the entire portfolio based on a) hygienic approvals, b) need for hygienic flanges, and c) SMV availability (e.g. T- series is not yet SMV enabled)

9. Remember, Only Micro Motion Offers a True Verification Method for Coriolis: Easy, Fast, While the meter continues to operate Full flow meter check: tests sensor components, tube stiffness, electronics, and wiring –Compares performance and repeatability to the day meter was calibrated –Loop-back checks of electronics and signal processing to ensure total system is functioning correctly Immediate results: no need to trend and interpret results Convenient: Test can be done with several interfaces and can be scheduled Safe and Easy: Does not take meter out of the line or stop the process Fast: Test only take 90 seconds SMV provides traceable reporting Internal/External Requirements SMV tracks meter changes to gain confidence in Flow Calibration Factor Difficult Processes Coriolis meters do not require flow conditioning Installation Effects Coriolis has no moving parts Meter Degradation

10. SMV YouTube video Smart Meter Verification video: https://www.youtube.com/watch?v=Kmp7eZaF3KM Zero Verification video: https://www.youtube.com/watch?v=dY_ENuE1H1k

11. SMV & AMS

12. Additional Benefits w/ AMS & Prolink Enables complete test traceability –Captures meter identification, configuration, and fingerprint –Test conditions recorded for user, date, time and process conditions Scheduling –Test automatically runs on user defined interval –Print or Save a Report of Results SMV Report SMV Test via Prolink

13. Meter Verification SNAP-ON

14. Launch Meter Verification From Device Menu

15. Reading Sensor Information

16. Enter Test Information

17. Start Meter Verification Test

18. AlternateAlternate Older transmitters may have limited options for Output Behavior

19. Running Test Progress

20. Saving Meter Verification Data

21. Test Results are Displayed

22. Click Next for Detailed Results

23. Display or Print Full Report

24. Results Documented in Audit Trail

25. Meter Verification Scheduler

26. Launch Scheduler From Tools Menu

27. Enter Optional Information Report SettingsTester InformationEmail Settings

28. Add Task

29. Set Task Properties and Frequency

30. Task Is Now Scheduled

31. Example AMS.OPCServer Data

32. What To Look For enable_meter_verification –Provides the current meter verification test state –0 = idle, disabled, abort –1 = normal verification (seen when hold last measurement or fault is selected) –6 = background meter verification (seen when continue measurement is selected) device_specific_status_4 –Provides meter verification test status –0 = None, pass –1 = A032, meter verification in progress, output fixed –2 = A033, tube not full (not sure this is associated with meter verification test) –4 = A034, meter verification failed –8 = A035, meter verification aborted –This item is bit enumerated so you should look at applying a mask for bit 2 only.

33. Committed to solving your toughest challenges