2014 Analytical Services Program (ASP) Workshop Albuquerque, NM 87104 September 16, 2014

1. Laboratory Information Management System (LIMS):A Tool for Enhancing Laboratory Quality Management Implementation 2014 Analytical Services Program (ASP) Workshop Albuquerque, NM 87104 September 16, 2014 Bryan B. Bandong Chemical Sciences Division Physical & Life Sciences Directorate

2. What is a LIMS? • LIMSis a computer program that is used in the laboratory for the management of samples, laboratory users, instruments, standards and other laboratory functions such as invoicing, plate management, and work flow automation. • Today's trend is to move the whole process of information gathering, decision making, calculation, review and release out into the workplace and away from the office. • LIMScan be client-server or PC-based, and is increasingly becoming web browser-based and provides a large assortment of functionality.

3. What is a LIMS? (continued) • With the advent of search-oriented web architecture, a LIMS becomes a complete enterprise resource planning integrating several data sources and processes of an organization into a unified system. • Uses multiple components of computer software and hardware to accomplish integration • Uses a unified database to store data for the various system modules

4. LIMS is more than software! It is a process of integration that encompasses enterprise or laboratory workflow combined with user input, data collection (instrument integration), data analysis, user notification and delivery of information and reporting. LIMS are complex systems that integrate hardware, software, people and procedures!

5. Drivers that lead to need for LIMS? • Increasing demands on technical managers and corporate executives (higher efficiencies and productivities) • Quality systems, such as ISO and Six Sigma, require rigorous testing documentation and analysis traceability. • Regulatory systems, such as GLPs, GALPs, GCPs and GMPs, require examination of manufacturing and analysis components together with meticulous records of every action and results. • Customers routinely insist on auditable schedules and thorough documentation for doing business. Data archiving, retrieval, and auditing must provide traceability, accountability, and compliance with regulations.

6. What is “traceability”? Traceabilityis defined as “the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.” [NIST] • traceability includes accountability to customers, regulatory, agencies, and quality systems. • It extends to recordkeeping, sample tracking, staff training, certification, maintenance, and more LIMS establishes links between samples, storage conditions, test dates, analyst certifications, instrument calibration, and testing parameters as well as interfaces to instrumentation an easy reality! [ISO 17025 compliant!]

7. LIMS creates a seamless organization where… • Instruments used are integrated in the lab network; receive instructions and work lists from the LIMS and return finished results and raw data back to a central repository where the LIMS can update relevant information to external systems. • Lab personnel perform calculations, review results and documentation using online information from connected instruments, reference databases and other resources using electronic lab notebooks connected to the LIMS. • Management can supervise the lab process, react to bottlenecks in workflow and ensure regulatory demands. • External participants (department, company) can place work requests and follow up on progress, review results and print out analysis certificates and other documentation (perhaps even historically).

8. Automatic data flow monitoring… Good (Automated) Laboratory Practices Continuously Monitored • Review and Approval • Resubmit for Testing • Re-sampling/ Investigate • Release with Electronic Signatures • Sample • Login • Login by Sampling Program • Double Data Entry • Barcode Labels – Printed • Sample Receipts - Issued • Work Assignment • Samples – Organized • Work Lists – Issued • Instrument Parameters – Sent • Results • Entry • Manual or Automatic Calc’ns • Integrated Data Capture Utility • Non-Numerical Data Archival • Online Validation and Flagging • Reports and Queries • Intuitive Query by Example • Integrated SQC • Trend Analysis • Performance Testing • Integrated Crystal Reports • Export to Desktop Applications • Enterprise Updates Sample Collection & Storage Mngt. Sample Receipt & Preparation Sample Testing & Analysis Quality Assurance Electronic Data Deliverable

9. Sample LIMS Workflow (page 1) Results & Data Entry Sample Login Review & Approval Reporting Data Capture Work Assignment • LIMS provides for efficient lab operations & better resource management: • Proactively manages sample life cycle • Data tracking, review, and approvals • Instrument availability & maintenance requirements Document Management Continuously present workflow features Audit Trail Version Control Security

10. Sample LIMS Workflow (page 2) Sample Login • Dynamically understands sample information at login based on predefined conditions, rules, and actions. • Allow sample login despite incomplete information – perhaps allow for web-based sample login by client • Identifies and flags appropriate individuals for data analysis and data evaluation • Automatically reintroduces sample into the workflow once all data is completed. Work Assignment • A “task manager” interface can be setup to schedule activities involving work lists, instrument use and maintenance, reports and non-sample related work. • Real time and automatic evaluation of readiness of instruments and analysts’ workload in advance of sample assignment, minimizing interruptions.

11. Sample LIMS Workflow (page 3) • Allows entry by sample, worksheet, or spreadsheet • Alerts analysts when results are outside of expected specifications, enabling immediate attention and faster resolution of issue Results & Data Entry • Eliminates transcription errors by direct data capture from instrument-generated data and results files • Automatically checks samples status at the point of data writing • Flags exceptions and triggers pre-defined troubleshooting procedures and corrective action protocols Data Capture Document Management • Captures and archives non-numerical instrument data and records • Automatically routes documents with live links to previously registered documents, assuring analysts have access to latest procedures and appropriate information to complete tasks.

12. Sample LIMS Workflow (page 4) Review & Approval Reporting • Selective routing to assigned signature paths based on sample results • Signature paths can be customized for unique tasks and types of sampling • Ensures all appropriate authorizations are obtained for chain of custody and auditing purposes • Actively-triggered reporting automatically generates, publishes, and routes reports and certificates of analyses to individuals or groups • Enables users to select whether reports are sent to print or directed to the customer or stored on the server • Provides for seamless electronic data deliverable (EDD) reporting

13. Sample LIMS Workflow (page 5) • Captures and preserves all sample data and information, including data structure definitions • Allows auditors to clearly determine how legacy data was managed by reconstructing record as they existed at time of transaction. • Enables lab to upgrade with confidence, knowing sample history is secure • Role-based security allows for data entry and modification and user viewing privileges based on job functions • Streamlines task completion and error minimization by allowing the sample state to determine which fields are active or available. • Ensures all users are working with the most current procedures and data even prior to sample analysis completion • Prevents alteration of published data without appropriate routing and notification of users • Automates routing based on predefined conditions Continuously present workflow features Audit Trail Version Control Security

14. LIMS increases productivity… • Instrument interfacing • Data capture, reporting, charting, archiving • Instrument maintenance and calibration records • SRMs & calibration standards inventory • Personnel training database • Sample management • Sample login, tracking, archiving • Process pre-scheduling & scheduling • Work flow and work assignments • Reporting functionalities • Progress, backlog and exception reports • Chain of Custody • Invoicing and management reports • Certificate of Analysis • Calculations, verification, validation, approval • Trend charting (including TATs, rates, etc.) • QC requirements & tracking • Traceability & audit trail • Document management & version control

15. Benefits of having a LIMS? • The full automation of results entry reduces technician workload and eliminates transcription errors. • These database servers offer redundancy, high availability, fault tolerance, and strong security. • A single data archive format can be generated by different instruments, and data collection is easily updated when the instruments or their software are upgraded. • Data can be collected through the network, allowing simultaneous access to multiple instruments without requiring direct connection or even physical proximity. • It helps ease documentation of regulation compliance (test methods, training certifications for analysts, log books for instrument maintenance, instrument standards and control charts, MSDS and general material management and tracking). • Computerized records reduce paper use and lower the costs associated with manual filing, copying, and storerooms, while reducing handling errors and improving response times.

16. LIMS – Selection & Implementation

17. The LIMS Implementation Process

18. References on LIMS Laboratory Information Management Systems, 2nd edition (2002), Christine Paszko and Elizabeth Turner, NY: Marcel Dekker, Inc.

19. http://lbg.limsbook.com/

20. QUESTIONS ???