LABORATORY INFORMATICS

Growing at a compounded rate of over 20% for eight straight years required that processes and systems be reengineered.

 

Specialty Pharmaceutical Company Leverages LIMS for Scalability

Business and Technology Goals

A five fold increase in revenues over nine years was taxing the existing manual quality control systems. Growing at a compounded rate of over 20% for eight straight years required that processes and systems be reengineered to support quality control and regulatory compliance. With a strong commitment to growth, quality and regulatory compliance the answer was clearly a scalable, fully integrated LIMS implementation.

The processes and systems to manage sample test results, review test results, release inventory, and manage certificates of analysis had to be reengineered and automated. A LIMS system would provide the necessary scalability making it possible to sustain growth without adding laboratory personnel. But the effort had to be done cost effectively without compromising quality or regulatory compliance. It would require a team effort including the client, Applied Biosystems and LabAnswer.

Solution

Implementing and integrating a LIMS system into the existing environment will provide the throughput and scalability necessary to insure quality and FDA compliance. The implementation included the following customizations:

  • For each sample received in the laboratory a due date is calculated, a worklist is printed and all associated methods are printed. This helps the analyst to determine what they need “to do” for the day and to perform the testing more efficiently.
  • When the first result value is entered for a sample an expected release date is determined. This helps the laboratory to set appropriate expectations to the requester of the data as to when the results of the sample will be available.
  • Samples and submissions are automatically approved where possible after testing is completed.
  • The system does not allow a sample to be approved if an out of spec result has been entered until an investigation has been performed and closed. This helps to eliminate the accidental release of a lot that does not meet specifications.
  • The system automatically flags lots which are eligible for stability based on business rules.
  • The system automates the transfer and tracking of lot information between JD Edwards (JDE) Enterprise Resource Planning (ERP) and SQL*LIMS.
  • The system allows SQL*LIMS to download lot information, such as batch identifiers, quantities, etc., from JDE to create a lot in SQL*LIMS. Once analysis of the lot is complete, the system then automates the transfer of the lot disposition back to JDE to allow movement of the material. This automation not only reduces the time it takes to process a lot but also reduces the probability of transcription errors that could occur during lot creation and disposition.
  • The implementation of SQL*LIMS allowed the laboratory to scale to the increasing demands of production and the integration of SQL*LIMS and JDE allowed the client to quickly and accurately move materials through the laboratory.

Benefits

The integrated solution will increase throughput and scalability without the need to increase the size of the QC laboratory staff. This is accomplished through automation and integration with the LIMS systems via:

  • Real-time creation of lots for inspection in SQL*LIMS
  • Automated transfer of Batch/Lot specific information - reducing transcription errors
  • Automated transfer of lot disposition information – improving material movement