Implementing an application-specific LIMS solution increases productivity, efficiency and researchers’ time, while also ensuring adherence to all industry regulations.
The National Environmental Accreditation Conference (NELAC) standards published in 2003 were revised and made available in July 2011 as the new TNI Standard 2009. The NELAC Institute (TNI) Standard is based on ISO 17025 guidance. Implementation of this updated standard will become a reality in the next year by the respective accrediting bodies. Many already implemented the new standard in 2011. For water system operators and testing labs, not only does this require adherence with ISO 17025 standards, but it also requires analysis of at least five new contaminants and lower limits for existing contaminants, as designated by the EPA in its annual review. The resulting increase in sample management and data analysis workload necessitates an investment in an automated workflow.
By automating operations and integrating instruments, water operators and testing labs can increase capacity and sample throughput and build in regulatory compliance, while also reducing the costs associated with time spent on manual activities, such as recording data in paper notebooks or using spreadsheets to create reports. A laboratory information management system (LIMS) is a critical tool to meet the ongoing requirements of TNI standards, and help prepare for state, regulatory or NELAC audits with all defensible data properly documented and prepared.
Laboratory information management systems have been available for more than 25 years, helping laboratories manage their samples and laboratory processes. Many water laboratories currently use a LIMS for some activities; but on the whole, much of the sample and related data management is still done using manual collection and reporting processes with either paper lab notebooks or spreadsheets. The problem is, while this type of process may be comfortable and part of the “way we do things,” manual processes introduce a certain level of risk. They are error-prone, the data is not searchable or collaborative in any way and any manual process is more time consuming, taking lab managers and systems operators away from more value-added work.
Moving to a LIMS can be a challenging prospect for a water testing lab, but one that is becoming essential. By implementing a LIMS preconfigured to meet the needs of water system operators and testers, challenges are significantly reduced. With a LIMS designed to address the specific workflow and regulatory requirements of water testing labs, lab managers are enabled to make quick decisions or rapidly share information with management, in addition to being able to respond to ongoing regulatory and business demands. With a LIMS like the Water and Environmental LIMS developed by Thermo Fisher Scientific, water testing labs are able to establish protocols and documentation methods that meet NELAC compliance requirements and ISO 17025 guidelines. With specific functionality built into the LIMS to improve workflow and lab efficiency, reports can easily be automated to ensure full traceability, and the integrity of the lab’s data is assured. Any regulatory agency, such as the EPA or a state regulator, will require reporting of lab results in a standardized and structured format. A LIMS can easily store the sample data and collate it in the format appropriate for each regulatory recipient. A LIMS designed specifically for water system operators allows labs to be much more efficient by taking this data directly from the instruments and comparing it with the regulatory limits for various contaminants. Once the data is in the LIMS, a predefined set of templates for reporting can be used, allowing the lab to automate data output and enabling lab operators to spend significantly more of their time testing and processing samples. For commercial laboratory organizations, packaging and reporting results and the associated quality control data for clients is often the deliverable product, so automating the creation and delivery of this package can also trigger the invoice process.
A LIMS designed for water and environmental labs can significantly enhance a lab’s capability for any audit situation that requires evidence of controlled sample management, proper labeling and identification, records of all proficiency training for operators, instrument calibration schedules and full audit traceability of all records. For NELAC audits, which typically occur every two years, LIMS simplifies the audit process by enabling the lab to mine all sample-related data to give an end-to-end review. TNI provisions that the audit involve both a technical and quality system review, as well as the potential to review data over a five-year period—something that can be both challenging and time consuming in a paper-based environment.
LIMS for Nova Biologicals
Nova Biologicals, a NELAC-accredited lab in Texas and one of the nation’s largest providers of water testing for drinking and wastewater, has implemented a Water and Environmental LIMS solution to work closely with municipalities, utilities and federal and state authorities to meet the requirements of the Federal Safe Drinking Water Act. The standards for environmental testing in laboratories have become more rigorous over the last few years as new requirements have been introduced via NELAP (National Environmental Laboratory Accreditation Program) and the EPA. Meeting these stringent requirements for water and environmental samples has introduced labor-intensive procedures to ensure compliance, such as sample tracking, chain of custody, record keeping, demonstration of capability, document control, reagent and standards traceability, proof of training and reporting.
Prior to implementing the Water and Environmental LIMS solution, Nova managed its work using paper-based processes and an outdated LIMS, which would not sustain Nova’s growing business. A new system that would be user friendly, easily maintained, web-based, capable of complex reporting requirements and meet all regulatory requirements (GLP, GMP, NELAC, HIPAA, etc.) was needed.
The implementation of the Water and Environmental LIMS solution enabled Nova to centralize all data in a single database, track status and workflow throughout the lab, automate processes to eliminate error-prone redundant data entry tasks, manage documents such as SOPs and training records for audit purposes and traceability and enable efficient data migration to and from customers.
With the LIMS solution in place, Nova has improved knowledge continuity as well as customer service and responsiveness. In addition, Nova is better prepared for regulatory compliance and any NELAC or other audit process, staff time is focused on value-added activities and the use of paper-based systems has been significantly reduced, allowing the company to eliminate manual error-prone processes and improve data quality.