Migration to Paperless QC Micro

Transcription

1 Migration to Paperless QC Micro Featuring Marvin Thompson Manager, Quality Operations

2 Co-sponsors 2

3 Today s Presenters Marvin Thompson Manager, Quality Operations marvin.thompson@talecris.com Bob Toal Vice President btoal@modatp.com 3

4 60-Minute Agenda MODA Overview Presentation by Talecris Biotherapeutics Software Demo Interactive Q&A Wrap-up A copy of this presentation will be made available to attendees through a follow up . 4

5 Webinar Focus Areas Scope of the Talecris QC Micro Program Previous Processes & Need for Automation Key Requirements for New Solution & Selection Process Implementation & Validation Current State & Plans for Future Real-time Q&A with Marvin Thompson (Talecris) 5

6 Background: MODA Provide mobile data acquisition solutions that automate regulated manufacturing processes Focus: Life Sciences Industry Headquarters: Wayne, PA (suburban Philadelphia) World-wide sales in North America, Europe, and Asia Global network of technology and services partners 6

7 MODA Value Proposition 1. More science. Less paper. Quickly move from paper-intensive QC Monitoring & Analysis 2. Increase operational efficiency, improve quality, reduce costs MODA-EM offers mobile computing technology and advanced visualization tools 7

8 Representative Customers

9 Review & Analyze Process Collect Plan The Paper-based QC Process Example: QC Sampling and Lab Processing NO Print sampling schedule & labels per EM SOP Assign sampling activities to QC Analysts Reconcile planned samples with collected samples All samples accounted for? YES Close out sampling schedule per EM SOP NO Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media All samples collected YES Deliver sampling paperwork to QC Supervisor Deliver samples to Microbiology or Biochemistry for processing Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Results in range? NO Notification of Alert or Action YES Aggregate data Trend results Trends OK? NO Investigate excursion Report results YES 9

10 Review & Analyze Process Collect Plan The Paperless QC Process Example: QC Sampling and Lab Processing. 11 steps removed NO Print sampling schedule & labels per EM SOP Assign sampling activities to QC Analysts Reconcile planned samples with collected samples All samples accounted for? YES Close out sampling schedule per EM SOP NO Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media All samples collected YES Deliver sampling paperwork to QC Supervisor Deliver samples to Microbiology or Biochemistry for processing Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Results in range? NO Notification of Alert or Action YES Aggregate data Trend results Trends OK? NO Investigate excursion Report results YES 10

11 Paperless Efficiency Example Paper 8 hours Paperless 4 Hours = Savings 4 Hours 11

12 Automated Reports & Analytics 12

13 MODA QC Solution Vision Paperless, Automated Laboratory MODA-EM TM Mobile Data Acquisition Flexible Workflow Integration On-Demand Analytics Systems (ERP, LIMS, CAPA) Devices Media Improved Compliance Increased Productivity Expedited Decision Making

14 The Talecris Story Migration to Paperless QC Micro 14

15 Quick Facts: Talecris Global biotherapeutic and biotechnology company Discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas Headquartered in Research Triangle Park, NC (biotech hub) Regional locations in Toronto, Canada, and Frankfurt, Germany Primary manufacturing facility in Clayton, NC Fractionation capacity & contract manufacturing in Melville, NY 4,500+ employees worldwide 15

16 Scope of Talecris QC Micro EM program consists of monitoring: All classified facilities (non-aseptic areas) All critical utilities: WFI, RO water, Clean Steam, Compressed Gases Aseptic fill facilities and personnel Process equipment, in-process product bioburden, and in-coming raw materials Test methods include: Microbial and particulate testing for facilities EM workload: 30,000+ samples tested each month **This does not include any final product release testing EM lab: 24/7 with ~70 employees supporting production ops Microbial and endotoxin testing for process equipment, in-process product, and raw materials Microbial, endotoxin, and USP/EP/JP chemistry testing of critical utilities 16

17 Past Processes SQL*LIMS Scheduler and Core LIMS were used for sample scheduling and data entry/reporting EM LIMS is a customized version of the standard SQL*LIMS application The Core SQL*LIMS was not designed for Environmental Monitoring workflow EM Data were distributed over several disparate platforms; The following additional systems were being used: Excel Spreadsheets used for recording and trending In-Process sample results Microsoft Access DB used for storing Microbial Identification test results 17

18 Need to Automate Data entry and data review was 100% manual and very labor intensive. Large volume of paperwork moving through lab and clerical staff each day. Dedicated resources assigned to data entry and review into existing data systems. Manual paperwork review process prior to data entry results in significant lag times between test completion and data entry, approval and reporting. Volume of samples plus manual process increases probability of data handling and paperwork errors. 18

19 Key Rqts: New Solution (1 of 2) Paperless EM lifecycle Immediate access to EM results All sample and testing information is entered directly into computerized system at time of occurrence ( real time ). No reconciliation of transcription process required. Process owners will have access to test results immediately after interim or final readings due to results being entered directly into system. Greater flexibility in trending and reporting results User Friendly Designed for use by lab technicians actually performing EM work. Automatic notification of excursions through the use of system generated s 19

20 Key Rqts: New Solution (2 of 2) Mobile work stations for technicians to access system from manufacturing cleanrooms in the plant. Custom and ad hoc reporting for real-time and historical data analysis. Automatic tracking of sample and EM process. Consolidate multiple EM data systems into one. Scheduling of tasks; barcode label printing; sample collection; incubation; and sample off-testing. Eliminate Excel spreadsheets and Access databases. Notify lab supervisors if scheduled samples are not collected. Permit lab supervisors to easily schedule ad hoc & repeat samples. 20

21 Selection Process Researched literature, web sites, industry peers Attended PDA seminars on EM trending technologies Several vendors gave hands on demonstrations of their products. Requested top vendors to come to demonstrate product solutions to Talecris EM group Selected MODA to automate Talecris EM lab Acquired senior management approval and funding 21

22 Implementation & Validation 1 Configure MODA Install MODA: Dev, QA & Prod environments 2 3 Configure & with Sample Sites, Alert/Action levels, Test Methods, Sampling Plans, etc. install custom reports specified in System Requirements 4 5 System Validate system Documentation: installation, Requirements, IQ, functionality & OQ, Traceability, Test reports (cgxp) Method Verification 6 End User Training

23 Current Status Validation completed 4th Quarter 2009 System is operated and maintained by EM personnel IS is available for system support and troubleshooting. To ensure accurate training, paper based system is being used concurrently with automated system After all employees have demonstrated competency in using new system, paper-based system will be discontinued (est. May 2010) 23

24 Previous: Raw Data Collection 24

25 Now: Automated Field Data Capture Featured: MODA-FDC Cart Stainless steel cart Ergonomic tablet PC Docking station Thermal label printer Barcode scanner gun Proximity reader for RF badges Space for equipment Space for growth media 25

26 Now: Automated Lab Processing 26

27 Benefits Eliminated data entry and transcription errors Real time data entry EM results available to process owners faster Eliminated scheduling errors Part 11 Compliance Reduced personnel related deviations Enhanced reporting and analytics capabilities Instrument integration No wasting time looking for paperwork/missing paperwork Support for investigation activities Fewer corrections and documentation errors Quicker reviews Notifications for deviations and missed samples 27

28 Path Forward Expand MODA users to include manufacturing personnel. Reassignment of resources currently associated with data entry and review of paper based system after that system is discontinued. Integrate particle counters into system to allow automatic download of nonviable test results directly into MODA. Work with media vendors to incorporate bar-coding of media lot numbers on individual media plates to allow scanning of media lot number into test records. 28

29 Today s Cleanroom Source: Environmental Monitoring A Comprehensive Handbook cleanroom touch pads or computer terminals that allow for automated data entry IN THE ROOM. palm-pilot-type of data collection devices that can directly download to the computer system and allow for direct data transfer without risk of contamination. real time data for many of the chemistry and microbiology tests that must be performed. 29

30 Today s QC Micro Lab Source: Environmental Monitoring A Comprehensive Handbook analysis and trending of environmental data is essential to aid in the interpretation of process stability and assess overall control performance. EM Reports must be accurate, traceable, timely, and well-documented 30

31 Marvin Thompson Manager, Quality Operations Bob Toal Vice President Questions & Answers To submit a question, use the Q&A feature of WebEx (bottom right of your screen). If we do not answer a question online, we will be sure to follow up with an . 31

32 Wrap-up Personal Consultation: Bob Toal, (484) x133 Learn More: MODA: Talecris: 32