| Since early development stages in 1982, LIMS has assisted in the documentation and traceability in sample management as a knowledge-sharing tool. Madhavan Kayambu, of HCL Technologies, charts the growth and development of LIMS
A laboratory information management system (LIMS) is an application that is used for the management of samples, laboratory users, instruments, inventory management and other business functions, such as invoicing, plate management and work-flow automation. LIMS is designed specifically for analytical laboratory which includes R&D labs, in-process testing labs, quality assurance (QA) labs, and so on.
LIMS is probably best described as a program that watches everything that happens within the laboratory, and helps everyone working there. This is done by storing all transactional information within a central repository, which is further sorted and organised into various report formats which are customised based upon user requirement. If ‘laboratory’ is termed as a ‘business unit’, then LIMS can be termed as the enterprise resource planning (ERP) system of the lab.
LIMS DEVELOPMENT
Home-grown laboratory information systems have been in development since 1982. The primary aim of implementing a LIMS is to capture data of laboratory transactions that help with the traceability of samples at a later stage of drug development so that an investigation of failures and the identification of impurities can be acheived. The following chronology gives a concise view of the development of LIMS to assist documentation and traceability in sample management as a knowledge-sharing tool. LIMS was originally custom-developed in-house by organisations to streamline their laboratory data acquisition and reporting processes.
Since then, commercial LIMS products have been developed that have typically been proprietary systems, often developed by analytical instrument manufacturers to run on the laboratory instruments they manufacture (see Figures 1 and 2).
LIMS APPLICATIONS IN PHARMACEUTICAL INDUSTRIES
In the lifecycle of the drug, it is tested and analysed at several phases for its efficacy and safety before it is authorised by the regulatory bodies to be on the market where it continues to demonstrate it is both safe and effective. Regulations (GxP) insist on safe and effective storage of all the data collected at each stage and phase. The drug lifecycle process includes identification (chemistry), screening, preclinical and clinical bioanalysis, analytical chemistry, manufacturing R&D, quality control (QC), and all have unique needs and workflows – including complex batch management and testing needs. These multiple requirements necessitate enterprise-wide solutions and LIMS has rapidly evolved to manage these needs. |
