LIMS: A Critical Tool for Achieving and Maintaining Regulatory Compliance

Description:
Analytical testing laboratories face many challenges on a daily basis. This is especially true of regulated labs that need to achieve and maintain certain governmental and industry standards in their testing methods and reporting. Typical examples of regulatory bodies include the EPA, FDA, and a variety of state and local government agencies. There are also a number of standards bodies responsible for accreditation/certification including ISO and industry organizations such as the NELAC Institute in the environmental sector.

This presentation will highlight the role of a laboratory information management system (LIMS) in helping the laboratory achieve and maintain compliance with these government bodies and industry standards. We will review a checklist of LIMS capabilities that are specifically designed to ensure regulatory and industry compliance, and meeting the key requirements for ISO 17025 accreditation. This includes the growing importance of documenting full traceability in sample testing. The presentation will also feature a case study of several companies in regulated industries and the role that their LIMS has played in helping them meet their regulatory compliance requirements. The case study also discusses other significant benefits associated with the LIMS that have helped optimize the laboratory’s operations.

Speaker: Dr. Christine Paszko - Accelerated Technology Laboratories
Dr. Christine Paszko is the Sr. Vice President at Accelerated Technology Laboratories, Inc. a LIMS, laboratory automation and informatics firm. She received her undergraduate degree in Medical Technology (MT ASCP), with a minor in Microbiology from the State University of New York @ Buffalo, and her doctorate at the University of Maryland in Molecular Microbiology. Her unique career combines a Ph.D. with 25+ years of experience in working in laboratories and leveraging data management tools, LIMS and automation. She worked at the Water Quality Manger at the Metropolitan Water District of Southern California, where she gained an appreciation for laboratory automation and LIMS. Dr. Paszko has been helping laboratories understand regulatory compliance requirements (ISO 17025), leverage LIMS and automation to increase productivity, throughput and profitability.