What does LIMS mean in FDA?

Laboratory information management system

A Laboratory Information Management System, sometimes referred to as a Laboratory Information System or Laboratory Management System, is a software-based laboratory and information management system that offers a set of key features that support a modern laboratory's operations. Those key features include — but are not limited to — workflow and data tracking support, flexible architecture, and smart data exchange interfaces, which fully "support its use in regulated environments." The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics. The definition of a LIMS is somewhat controversial: LIMSs are dynamic because the modern laboratory's requirements are rapidly evolving and needs often vary significantly from lab to lab. Therefore, a working definition of a LIMS ultimately depends on the interpretation by the individuals or groups involved. Dr. Alan McLelland of the Institute of Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them correct, but each of them limited by the users' own perceptions."

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