1. B104 Lab Monitoring Remediation Project
Project Update February 18, 2010

2. Project Overview
1)Yokogawa chart recorders have a history of deviations in the labs. 2) Periodic Review of B104 automated LEQMS identified gaps to remediate.
DEVIATION REDUCTION: Temperature and humidity data loss from paper chart recorders, missed daily checks.
PROCESS IMPROVEMENT: Paper chart recorders require daily checks, change out of paper, fixing paper jams, storing of paper charts in GMP library. (fan the paper)
Change:
Upgrade paper chart recorders for temperature and humidity monitoring of approximately 80 pieces of lab equipment and rooms for all of B104. Decommission (paper chart recorders) and (LEQMS) system as a result of upgrade.

3. Yokogawa DX230P (DAQSTATION) Paperless Recorders
System
Yokogawa DX230P (DAQSTATION) Paperless Recorders
Area
No. of Units/Monitored Equipment & Locations
LEMS41 - B104 / Basement (Media Prep)
1/11
LEMS42 - B104 /1 (Chemistry)
1/26
LEMS43 - B104/2 (Purity, Development, Endotoxin)
1/25
LEMS44 - B104/2 (Potency, ID)
1/12
LEMS45 - B104/3 (Sterility, Micro Water Lab, Particulates)
1/19
Total Units/Locations
5/93

4. Remote Alarm Notification (Win-911)
System
Remote Alarm Notification (Win-911)
Area
No. of Alarms Monitored/Responders
LEMS41 - B104 / Basement (Media Prep)
20/2
LEMS42 - B104 /1 (Chemistry) – 3 shifts
30/10
LEMS43 - B104/2 (Purity, Development, Endotoxin)
48/9
LEMS44 - B104/2 (Potency, Micro-ID)
22/5
LEMS45 - B104/3 (Sterility, Micro Water Lab, Particulates)
32/8
System - Automation
Total Alarms/Responders
152/34

5. Monitoring

6. LEMS System Overview

7. LEMS System Overview

8. Project Details Total Budget: $224,000
Documents : 19 (Req; Des; Test Plan, Maint Strategy, etc.)
Test Cases Developed/Executed: 12/~ 100
Procedures/Tools Updated/Created: 1/8
Summary Reports: 2 (1 Test; 1 Val plan)
Systems to be Retired: (7)-Yokogawa paper chart recorders & Automation (LEQMS)

9. Risk Mitigation Strategies
Risk Assessment and Equipment FMEA executed.
All Testing done online with new LEMS production system.
Extensive Training: >100 Individuals received Data Historian LL training; Vendor (Yokogawa) onsite and Lilly project members setup and trained each Area of Labs.

10. Lessons Learned/Issues Resolved
DAQSTATION – Alarms do not latch
DAQSTATION –Alarm Acknowledge status not available to pass on via Kepware (Win-911 unable to stop calls if alarm acknowledged locally)
B104 Network impacted – IAT process did not flush out connectivity issues
Remote notification hardware unable to perform in Virtual Server environment
Integration between Parenteral engineering and labs - language, terminology, business practices and procedures handled differently.