Validation summary report and risk assessment of AICL (KP) LIMS

Abstract

LabWare LIMS is a full-featured, configurable, enterprise Laboratory Information Management System (LIMS). LIMS is a computerised system used to manage laboratory samples, equipment, results, workflow, users, and results and to generate reports. At AICL the LIMS system has a bi-directional interface with the Waters Empower Chromatography Data System and with SAP. The purpose of this report is to give a general overview of all the different aspects of validation required to introduce a LIMS computerised system into AICL. In this project I will detail specifically the risk assessment as this is an area of increasing importance with the regulators/inspectors and relatively new within the pharmaceutical industry. It details the items identified as 'high risk' from the FMEA and how these items were controlled and validated. At the time of this report being generated, the LIMS system has been introduced for use in the 'live' environment, but some of the existing modules of the system are still being developed i.e. stability samples and alert alarms monitoring. An external audit performed on the LIMS system post go-live is also detailed highlighting the non-conformance issues that arose during review of the system. In this project, validation of the AICL (KP) LIMS was executed. The key results showed that the AICL (KP) LIMS is qualified. Also a lot of important lessons learned throughout the duration of the project are highlighted.