SK Bioscience strengthens its global competitiveness through digital transformation (DT) of its R&D system.
SK Bioscience announced today that it has introduced and operated a Laboratory Information Management System (LIMS), the first in Korea to comply with Good Clinical Laboratory Practice (GCLP).
After completing the system construction and Computer System Validation (CSV) process for about a year from June last year, SK Bioscience applied the LIMS to its own clinical trials from September 20.
The LIMS introduced by SK Bioscience is based on the "BIOVIA ONE Lab" platform of Dassault Systèmes, a global software company, and tracks and manages all processes from sample receipt to analysis, storage, and shipment in real time.
This ensures data integrity, which includes completeness, accuracy, and consistency, unlike manual methods.
SK bioscience also built a "Business Intelligence (BI)" dashboard to analyze the suitability of the accumulated data and monitor the progress of the trial in real time.
Through this, all processes and results of clinical trial immunogenicity analysis are recorded in real time, and result reports are automatically generated to enhance work efficiency and management systematicity.
With the introduction of LIMS, SK bioscience plans to further accelerate its IT advancement for global expansion. Recently, the FDA has required "FDA 21 CFR Part 11," an electronic record management regulation, for pharmaceutical raw materials and finished products sold in the U.S., which is expected to further strengthen the competitiveness of products utilizing LIMS.
"To enter advanced bio and vaccine markets such as Europe and the U.S., it is essential to comply with global regulations and standards," said Hwang Jae-sun, head of SK Bioscience's Digital Innovation Center. "Digital capabilities that meet global standards, such as LIMS, will play an important role in securing product competitiveness and collaborating with various overseas partners."
