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Application can also enhance the lab's capability for any audit situation that requires evidence of controlled sample management, proper labeling and identifi- cation, records of all proficiency training for operators, instrument calibra- tion schedules, and full audit traceability of all records. For NELAC audits, which typically occur every two years, a LIMS simplifies the audit process, since it enables the lab to mine all sample-related data to provide an end- to-end review of all related information. TNI provisions that the audit will involve both a technical and quality system review, as well as the potential to review data over a five-year period — something which can be both challenging and very time consuming in a paper-based environment. A LIMS Application — Nova Biologicals Nova Biologicals, a NELAC-accredited lab in Texas and one of the nation's larg- est providers of water testing for drinking and wastewater, has implemented a Water and Environmental LIMS solution from Thermo Fisher Scientific 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 environ- mental 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 require- ments for water and environmental samples has introduced labor-intensive pro- cedures 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 Prior to implementing the LIMS solution, Nova Biologicals managed its work using paper-based processes and an outdated LIMS that could not sustain Nova's growing business. A new system was required that would be user friendly, easily maintained, configurable to Nova's needs, web-based, capable of complex reporting requirements, and in compliance with all regulatory requirements (GLP, GMP, NELAC, HIPAA, etc.). The implementation of the LIMS solution enabled Nova Biologicals to central- ize 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 been able to improve knowledge continuity as well as customer service and responsiveness. In addition, Nova is better prepared for regulatory compliance and any NELAC or other audit pro- cess, 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. Jeanne Mensingh is president and founder of Labtopia Solutions, which provides tailored quality system advisory services to help business meet regulatory requirements and enhance perfor- mance. Labtopia Solutions is part of Labtopia, Inc. (formerly EM2 Management Solutions), a quality assurance/quality control solutions company based in Houston, TX. Colin Thurston is product strategist for process industries in the Informatics business at Thermo Fisher Scientific. He is based in the United Kingdom. For more information about Nova Biologicals, a full case study may be found at www.thermoscientific.com/waterresources. 54 Water Online The Magazine, Wastewater Edition ■ wateronline.com