Achieving ISO 17025 Compliance Using LIMS

Oral Presentation

Prepared by A. Gade, S. Paul
CloudLIMS.com, 142, Electronic Complex, Indore, M.P., 452010, India


Contact Information: aditi@cloudlims.com; +1-302-789-0447


ABSTRACT





Environmental testing plays a very crucial role in providing information to manufacturers about the safety and efficacy of their products. Ensuring safety of products is a must before they reach their customers as hazardous environmental materials can have serious effects on human health and environment. Different environmental laboratories provide different testing services including analysis of soil, sediment, water, air, gas, biota, industrial hygiene, and radiochemistry. Environmental testing laboratories face unique challenges in delivering accurate, consistent and traceable results. They also need to track the items that were used during the testing process back to lot numbers. Furthermore, the current economic factors put additional pressure on these labs to standardize their workflows and processes. Standardization is required to achieve ISO 17025 compliance and to demonstrate technical competency of laboratories for providing valid and accurate test results. To overcome these challenges and to meet regulatory requirements, a Laboratory Information Management System (LIMS) plays a significant role. The new ISO 17025:2017 standard primarily includes general requirements, structural requirements, resource requirements, process requirements, and management requirements. A LIMS plays a pivotal role in the documentation of Standard Operating Procedures (SOPs), technical competency requirements of analysts directly or indirectly involved in performing tests and calibration of analytical instruments, recording of test results and generation of reports. Additionally, it helps in documenting the process of receiving, evaluating, and addressing complaints, corrective actions taken, customer feedback and audit records for all laboratory activities. Since regulations and testing protocols are dynamic, a robust and configurable LIMS can provide the necessary flexibility to cope with changing business demands and practices. Besides, integrating the LIMS with analytical instruments can eliminate the time-consuming manual process of uploading test results and can minimize transcription errors. By implementing a LIMS, environmental testing laboratories can increase sample throughput as well as establish protocols and documentation methods that meet ISO 17025 guidelines.