The National Institute for Biological Standards and Control (NIBSC) is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. NIBSC is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the MHRA and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health. NIBSC is the Official Medicines Control Laboratory (OMCL) for the United Kingdom. As such, NIBSC undertakes independent testing of batches of biological medicines intended for use in the UK or elsewhere in the EU. The analyses carried out are largely defined by the product license or dictated by scientific expertise of the product, and are against a range of specifications and leads to issue of authorisation to use that specific batch of product. NIBSC require a fully functional Laboratory Information Management System (LIMS) to manage this work. The LIMS may be defined as a computer system that manages information/data produced in laboratories and retains this data in context. Amongst its many requirements, the LIMS must be able to deal with one-to-many and many-to-one relationships, the LIMS ought to be able to track packages as they arrive to the Institute, manage data from the scientific areas and then produce a Certificate of Batch Release. This LIMS must work within a Quality System auditable to ISO 17025 and validated in line with current GAMP guidelines and best practice. Ideally the LIMS should be Web enabled and open to the customer in terms of system and database design, include a user-friendly graphical user interface, be appropriately menu driven, use database technology that is consistent with the data layer architecture standards already in place within the Institute, be fully ODBC compliant and mineable using third party applications such as Crystal Reports/Business Objects/Microsoft Access etc. Finally the LIMS must be sufficiently flexible to meet current and future requirements, e.g. to comply with changes in national or European legislation. It is essential that there is full audit of all changes on the system, including input of results, modifications to report structures, customer records, address records, test records, sample records and any other data that is held within the LIMS. Auditing changed data should be viewable via an easy to use graphical interface.