LIMS White Paper

The Role of LIMS in Meeting Biobank Regulatory Requirements and Ensuring Operational Quality

Introduction: Biobanks (which include both specimens and databases) contain a huge amount of personal health information, requiring firm regulatory oversight to guarantee privacy and ethical use of these materials. To facilitate the complex organization and interplay between biobanks and research and development, companies and institutions are increasingly using laboratory information management systems (LIMS), biobank management software which provides, at a minimum, data tracking and data exchange interface support. Because of the automation inherent in biobank LIMS, they have proven invaluable not only in the management of biospecimens, but also in the compliance to multiple and complex regulatory requirements both in the US and worldwide. In the US, they play an ever-important role in the Food and Drug Administration (FDA) approval process for new drug applications (NDAs).

Biobanks were initially developed at the time of the Human Genome Project (HGP) in the 1990s to enable researchers the ability to access biospecimens. The advancement of the use of biobanks remains one of the major outcomes of the HGP. Today, biospecimens are used to identify the genetics and other causes of disease in the search for medical treatments, personalized diagnostics and breakthrough drugs, and the samples stored in biobanks serve as the basis of translational science and drug development. A major goal for the use of biospecimens is to develop “personalized medicine” that improves individualized medical treatments by incorporating molecular and genetic information.

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