The implementation of a compliant Lims is often victimised by 'scope creep', with costs rising up to five times above original estimates, forcing the continued funding of a never-ending project.
However, a white paper examines an alternative 'Thin Lims' strategy that promises to cut the technical resources and costs required for deployment in half.
The paper is entitled 'Thin Lims, Thick Lims - New IT Implementation Strategy for CGMP Quality Informatics - How to Complete a QC/QA CGMP Lab IT Architecture with Half the Technical Resources in Half the Time'.
It was derived from one-on-one in depth interviews with IT managers involved with traditional Lims projects in CGMP quality operations.
Over the last few years, the Thin Lims strategy has been presented by major pharmaceutical, generic and biotech companies at the annual Imacs (International Meeting on Automated Compliance Systems) conference.
In short, the Thin Lims strategy is the implementation of a commercial Lims in combination with a GMP lab execution system.
The Lims functions are narrowly defined and fixed for quick implementation and are usually 'supervisory and administrative functions', while the lab execution system is an off-the-shelf platform for lab 'method functions' that include all data and metadata compliance documentation and instrument integration.
Through this architecture, the CGMP lab operations are totally automated yielding productivity improvements of 25 per cent or more, with cycle time reductions in excess of 50 per cent.
Moreover, project cost considerations include a 50 per cent reduction of traditional Lims implementation requirements, and a cutting of project completion times in half.
The white paper outlines the key definitions, architecture and cost/benefit considerations for a Thin Lims v Thick Lims implementation strategy in CGMP quality operations.
It is authored by John P Helfrich, vice president, GMP Automation Programs at Velquest Corporation.
The paper is available for download from the Velquest website.
