LIMS: A Critical Tool for Achieving and Maintaining Regulatory Compliance

Transcription

1 23 rd Annual Good Laboratory Practice Conference LIMS: A Critical Tool for Achieving and Maintaining Regulatory Compliance Presented by: Ken Ochi, Accelerated Technology Laboratories, Manager of Global Marketing

2 Agenda Working in a Water or Wastewater Laboratory in a Regulated World ISO The Standard for Testing and Calibration Laboratories Virginia Environmental Laboratory Accreditation Program (VELAP) LIMS: A Critical Tool for Regulatory Compliance LIMS CASE STUDY: Citizens Energy Group LIMS CASE STUDY: Prince William County Service Authority Wrap-up / Q&A

3 Accelerated Technology Laboratories >23 Years of Expertise in LIMS & Laboratory Automation Our LIMS solutions are installed in >575 laboratories with >50,000 users worldwide Environmental is our #1 market segment ISO 9001:2008 Certified ATL Advantage Program

4 Living in a Regulated World

5 Safe Drinking Water and the Importance of Regulation

6 Regulatory Compliance Why It Matters It s the law - implications for non-compliance include: Financial penalties (ex: fines, refunds) Laboratory inspections/audits by government agencies Product recalls Loss of laboratory accreditation Future viability of business at risk Regulations are designed to protect the public Safe drinking water (EPA, state and local regulations) Safe food supply (FDA) Safe pharmaceutical supply (FDA) Safe consumer products (CPSC) Safe working conditions (OSHA)

7 ISO The Standard for Testing & Calibration Laboratories ISO is the primary standard for evaluating the competence of testing and calibration laboratories. In the environmental sector: Commercial environmental labs, water/wastewater utilities, electric/nuclear power utilities National Environmental Laboratory Accreditation Program (NELAP) Maintained by the NELAC Institute Non-profit organization whose mission is to foster the generation of environmental data NELAP is modeled after ISO and has a well-documented process for becoming a NELAP-accredited laboratory.

8 ISO The Standard for Testing & Calibration Laboratories ISO is also an important standard for laboratories in other regulated industries like: Food & beverage and agriculture (regulated by FDA, USDA) Pharma (FDA) Consumer products (CPSC) Manufacturing (OSHA to meet industrial hygiene standards) The key benefits for labs who have achieved ISO accreditation include: Provides ongoing recognition of testing competence to customers, suppliers, regulatory agencies Provides lab with validation that they are performing their lab work correctly and to appropriate standards

9 Virginia Environmental Laboratory Accreditation Program (VELAP) All laboratories in Virginia that provide air, waste, or water data to the Virginia DEQ are required to become certified under the Virginia Environmental Laboratory Accreditation Program (VELAP). 1 VAC, Chapter 45: Certification for Non-commercial Laboratories 1 VAC, Chapter 46: Certification for Commercial Laboratories Commercial Labs: Must meet requirements for 2009 TNI Standard Non-Commercial Labs: Must meet a limited version of the 2009 TNI Standard VELAP is managed by the Virginia Division of Consolidated Laboratory Services (DCLS)

10 LIMS - Wikipedia A Laboratory Information Management System (LIMS), sometimes referred to as a Laboratory Information System (LIS) or Laboratory Management System (LMS), is a software-based laboratory and information management system with features that support a modern laboratory's operations. Key features include but are not limited to workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments. "The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics. A LIMS is a software-based system with features that support a modern laboratory's operations. Accelerated Technology Laboratories, Inc. Confidential

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12 LIMS A Critical Tool for Regulatory Compliance ISO Requirement Does LIMS Provide Functionality? Traceability?? Personnel training records?? Instrumentation calibration/maintenance?? Chemical inventory?? Document customer complaints/resolution?? Corrective Action / Preventative Action (CAPA)??

13 LIMS A Critical Tool for Regulatory Compliance A Complete LIMS Solution Should Also Include Dashboards Instrument Interfacing Bar coding (1 and 2D)

14 LIMS Case Study: Citizens Energy Group Mark Gray Lab Services Manager

15 The New Citizens Energy Group Citizens Energy Group is a broad-based utility service company, providing natural gas, thermal energy, water, and wastewater services to about 800,000 people and thousands of businesses in the Indianapolis area. At Citizens, our vision is to fulfill the promise of the Trust to serve our customers and communities with unparalleled excellence and integrity.

16 Citizens Energy Group Lab Services 80-85% Drinking Water Analyses 13 DW Plants SDWA Compliance; RTCR, DBP, Pb/Cu, Crypto, Giardia, UCMR, etc. Process Monitoring and Control Raw Water Early Warning System; spills, browns fields, etc. MIB, Geosmin, Algal Toxins, etc.--monitoring and Control 10% NPDES and IPP DW, Steam, WF and CSM Water 5% R&D, Process Improvement, etc. 5% Customer Support, Reservoir Treatment Support, IUPUI Partnership Support, etc. ~1800 Samples/Month ~8500 Analyses/Month ~13,000 Parameters/Month

17 Why LIMS?

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19 Our Lab Data Handling History Lab Notebooks prior to mid 1990 s Data management totally by hand Labor intensive / Slow TAT Prone to errors Precision and Accuracy based on how sharp your pencil is

20 Our Lab Data Handling (Cont d) Spreadsheets Mid 1990 s to 2004 Data management computerized Less labor / Faster TAT Prone to data entry errors Precision and Accuracy improved

21 Our Lab Data Handling (Cont d) First LIMS in April 1, 2004 General management of data computerized 15 months of config time Labor hog Less labor / Faster TAT Less prone to entry errors autoimportation Accuracy improved Batch QAQC Control charting capability Trending using data from multiple sources much easier

22 Our Lab Data Handling (Cont d) Upgraded to a new LIMS in May 2015 Data management specific to water and wastewater methods Much faster config; more out-of-the-box functions Less labor Improved data importation Batch QAQC, control charting capability, etc. Calendar/scheduler for compliance events Standards expiration, chemical inventories, customer complaint tracking, custom report creator, invoicing, etc. etc. etc.

23 Demonstrating Compliance Lab Services Certs: Indiana State Department of Health (ISDH) ISO or NELAC DMR-QA requirements Citizens Utilities--SDWA, CWA, NPDES, IPP SDWA, NPDES, IPP Citizens Lean and Six Sigma (CLASS initiative) Water Utility--Partnership for Safe Water

24 The Partnership for Safe Water is a voluntary effort between six drinking water organizations and more than 200 water utilities. The goal is to provide a new measure of public health protection to millions by implementing protection programs where legislation or regulation does not exist. The Partnership provides operators, field staff, managers and administrators with tools to assess the performance of treatment plants and distribution systems. Utilities participating receive many benefits including: Procedures, software and manuals to implement and monitor water quality improvements Access to summary data from other utilities that enable comparison with industry benchmarks Participate in program committees with other utilities to share best practices Participation assures regulators (EPA, state agencies) that the utility is able to meet more stringent regulatory requirements For more information:

25 LIMS A Critical Tool for Regulatory Compliance ISO Requirement Does LIMS Provide Functionality? Traceability Personnel training records Instrumentation calibration/maintenance Chemical inventory Document customer complaints/resolution Corrective Action / Preventative Action (CAPA) YES YES YES YES YES YES

26 LIMS Case Study: Prince William County Service Authority Jojean Bolton Laboratory Manager

27 Organization Overview Prince William County Service Authority (PWCSA) provides safe, reliable drinking water and environmentally-sound water reclamation services to over 250,000 customers in Prince William County, VA. PWCSA s vision is to be a nationally acclaimed leader in providing clean water and excellent customer service through innovative business practices, community partnerships and environmental stewardship. The plant infrastructure consists of: Three water treatment plants Wastewater treatment plant Water/wastewater laboratory

28 Facilities Overview Water Treatment Plants James J. Corbalis Jr. Plant (225 MGD) Frederick P. Griffith Jr. Plant (120 MGD) City of Manassas Plant (5 MGD) Wastewater Treatment Plant H.L. Mooney WW Plant (24 MGD) Laboratory Internal water/wastewater testing H2O Quality Lab (Commercial water quality testing)

29 Laboratory Overview 16 employees (includes field staff) and runs 6,000 10,000 tests per month DW and WW testing for utility compliance, commercial customers and system monitoring 6,200 sq. ft laboratory opened in 2015 as part of Durward E. Grubbs Environmental Education Center (at Mooney WWTP) Certified Virginia Environmental Laboratory Accreditation Program (VELAP) Chapter 46 Commercial Laboratory Certified for Safe Drinking Water Act (SDWA) NELAP Accreditation

30 National Environmental Laboratory Accreditation Program (NELAP) Listed in The NELAC Institute (TNI) Accreditation database as H2O Quality Laboratory a Division of the Prince William County Service Authority Fields of Accreditation (FOA) are listed on the right

31 What does regulatory compliance mean for PWCSA? Adherence to VELAP Chapter 46 requirements for commercial laboratories Adherence to Virginia Waterworks regulations Under provisions of the Safe Drinking Water Act (SDWA), the lab must be certified by the Division of Consolidated Laboratory Services (DCLS) to perform micro and chemical analysis of drinking water. The Office of Drinking Water (ODW) of the Virginia Department of Health has been given responsibility to oversee the SDWA requirements DW compliance = TCR, DBP, Lead and Copper, etc. (Submitted Lab-to-State) WW compliance = according to permit NPDES DMR submitted electronically

32 LIMS plays critical role in achieving regulatory compliance The LIMS generates traceable data reports for customers Reduces errors and improves efficiency by integrating data from instruments to LIMS Ability to export data from LIMS to separate database used by plant operations (for DMR submission) Ability to monitor sample testing in real time by generating QC charts Integration of barcode and scanning technology to LIMS eliminates inefficiency and mistakes The LIMS exports data as csv files for digital submission of regulatory data to state (Lab-to-State) The LIMS creates sample disposal logs for traceability

33 LIMS A Critical Tool for Regulatory Compliance ISO Requirement Does LIMS Provide Functionality? Traceability Personnel training records Instrumentation calibration/maintenance Chemical inventory Document customer complaints/resolution Corrective Action / Preventative Action (CAPA) YES YES YES YES YES YES

34 Questions? THANK YOU! Stop by the ATL booth (Booth #25) for more discussion on LIMS and laboratory automation. I also want to thank our customers who made the case study portion of our session possible. Citizens Energy Group Mark Gray, Lab Services Manager Prince William County Service Authority Jojean Bolton, Laboratory Manager

35 23 rd Annual Good Laboratory Practice Conference Questions? Visit ATL in Booth #25