Industry Case Studies, Life Sciences

Leveraging LIMS to Enhance the Production Environment

Background:
A Fortune 500 manufacturer of therapeutic medications sought to expand their custom Laboratory Information System (LIMS) to include a new hierarchy. This expansion would necessitate some significant modifications to the existing LIMS. The client required full integration of custom components into their system while meeting all business requirements.

Situation:
The client developed a new LIMS, which provided an information backbone for batch or lot dispensation in regard to sample management. The new custom system expanded the normal LIMS function from general sample management tasks to raw materials management, lot and order tracking, and to conduct test management. Additionally, the new LIMS added the "container" class to the normal LIMS hierarchy (lot, job, sample, and test). This addition meant that the normal internal processes and workflow of the old LIMS had to be custom reconfigured to meet the client's business requirements. These requirements included capturing the laboratory testing information, tracking it to a specific lot and order hierarchy, providing detailed audit capability, and capturing exclusive procedures, policies, and business regulations. This information would then need to be incorporated into the proprietary programming language of the LIMS. The goal of this project was to aggressively implement the new LIMS in an effort to meet business demands.

Solution:
According to the requirements of the client, there were four functional areas that EnteGreat worked with to develop for the LIMS: chain of custody, raw materials, sample management, and calculations. The chain of custody dealt with providing tracking and auditing of the sampling management system through production. Raw material concerns revolved around genealogy information for lot and job creation, modification, and removal. The ability to enter test results and associate results with specific points in the hierarchy was paramount for sample management. Finally, EnteGreat provided a library of calculations used throughout the application for a variety of purposes, from converting units, aggregating results, and providing statistical methods. EnteGreat utilized the LIMS vendor's proprietary programming language to customize the LIMS according to the client's specifications. The business requirements for this project were established for design parameters, and then the LIMS was customized and those modifications tested.

Benefits:
The client received substantial benefits from the project, as the proprietary LIMS system was reconfigured to better meet the requirements for their production environment. EnteGreat developed a complete audit trail of all testing transactions in order to rectify the differences in custody process between the client and the actual sample management system, making validation and long term support easier. Because the client placed the highest value on their operational requirements, this project entailed a great deal of custom development in the LIMS environment. At the end of the assignment, however, the client was able to meet all of the technical and business objectives for this project.