In 2010, ImClone, a wholly-owned subsidiary of Eli Lilly implemented a fully automated LIMS process from STARLIMS business to replace the paper based process used in their quality testing labs. The automated LIMS system enabled ImClone to accommodate a 25% increase in testing volume while holding headcount steady. The manufacturing of pharmaceutical drugs is a complex process requiring multiple validation checks to ensure patients get a safe and efficacious product. ImClone has implemented rigorous testing processes to ensure manufactured lots meet stringent quality control standards. The quality control process takes samples off manufacturing lines and tests them against defined test processes to ensure all quality standards are met.
Scientists in the laboratory were capturing results and ancillary data associated with the test method in log books or other forms. The results were then transcribed manually into the STARLIMS LIMS application. The manual component introduces delays and the potential for errors due to human transcription. In addition, the process required manually tracking a lot of data.