"Thin LIMS, Thick LIMS - New IT implementation Strategy for cGMP Quality Informatics"
Today, LIMS initiativess in life science GMP environments are comprised of two functional requirements.... Lab Administration tasks and Lab Execution tasks. Early phases of a LIMS deployment plan are focused on the lab administration tasks including: sample login and tracking, specification management, stability management and data reporting and trending. In most companies, these functions are well defined and generally first to implement. The key challenge in a "total LIMS plan" is connecting the administration tasks with the analytical work, or lab execution tasks, performed by analysts. Often the LIMS automation tasks at the lab level are compromised with numerous data input forms, result entry forms, or a hybrid system of paper and some direct electronic connection with instruments and methods. These tasks are generally the most costly to implement and make up the majority of a total LIMS custom implementation cost.
LIMS vendors and consultants fail to discuss the large level of custom coding that is needed to automate the lab workflow tasks and required cGMP documentation needs. The traditional LIMS deployments can be characterized as "Thick LIMS" projects and can often be 2-5 times the original estimates in time and budget for completion.
The solution to these issues is a new "Thin LIMS" deployment. Over the last five years, this Thin-LIMS strategy has been presented by major pharmaceutical, generic and biotech companies at the annual IMACS conference. In short the "Thin LIMS" deployment is the implementation of a commercial LIMS in combination with a GMP Lab Execution System. The LIMS functions are narrowly defined and fixed for fast implementation and are usually "supervisory functions" while the lab execution system is an off-the-shelf platform for lab "method functions" that include all data and metadata compliance capture, documentation, instrument integration and reveiw processes.
The ultimate value of your LIMS includes both the administrative controls and the productivity gains of your lab staff in executing the test methods with the minimization of compliance risks in proper documetation under cGMP conditions. The Thin LIMS implementation strategy will get you to the full implementation of your Laboratory Informatics plan in less time, and less cost then your existing LIMS budget.
The information contained in this web briefing was derived from one-on-one interviews with IT managers involved with traditioal LIMS projects in cGMP quality operations.
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