LIMS: Enabling Biobanks Achieve ISO 20387 Accreditation



A biobank is a laboratory facility that accepts, processes, stores, and distributes samples and data, for use by research institutions. The role is to store these collections and to keep biospecimens in a safe physical location while maintaining quality so that researchers can access them, and the data associated with these biospecimens. Biobanks play an essential role in biomedical research.
ISO recently published a new standard specifically for biobanks, ISO 20387:2018, in response to the growing role of biobanks within the life science industry. This standard covers requirements for all aspects of managing biobanks, including structural, personnel, facilities, processes, and equipment. The benefits of a biobank being accredited make any effort worthwhile as it promotes confidence, assures reliability, reduces costs, and boosts efficiency. Furthermore, ISO 20387 promotes transnational harmonization of biobanking practices and fosters worldwide collaboration to further advance research in healthcare and personalized medicine. 
Biobanks can take advantage of informatics tools, such as a biobanking LIMS, to securely manage data, safeguard the personal health information of patients, assign role-based rights to staff for several activities, and define quality management systems to make available samples that are fit for use in research. This, in turn, enables biobanks to meet the requirements of ISO 20387 and meet the needs of the research community. 

A LIMS in the cloud offers several advantages for managing biobank data. It leverages the power of the cloud for resource utilization, storage flexibility, security, and scaling benefits, like no upfront investment is needed for hardware such as servers or networks.

Learning Objectives:

1. Discuss the importance of ISO 20387:2018 accreditation.

2. Discuss general, structural, resource, process, and quality management system requirements of ISO 20387 compliance.

3. Discuss how biobanks can comply with ISO 20387 to demonstrate operational competency and maintain high-quality, annotated samples fit for use in research.