SK Bioscience Embarks on 'Digital Transformation'... "LIMS Operation Begins"

SK Bioscience announced on the 20th that it will strengthen its global competitiveness through the digital transformation (DT) of its research and development (R&D) system by introducing and operating the 'Laboratory Information Management System (LIMS)' as the first clinical trial specimen analysis institution (GCLP) in Korea. Since June last year, the company has been building the system and conducting the computer system validation (CSV) process, and from this day forward, LIMS will be applied to clinical trials conducted independently.

Researchers at SK Bioscience are analyzing clinical trial data using the Laboratory Information Management System (LIMS).
[Photo by SK Bioscience]

LIMS is based on the ‘BIOVIA ONE Lab’ platform by Dassault Syst?mes, a global software company, and features real-time tracking and management of all processes from specimen receipt to analysis, storage, and release. Unlike the traditional manual method, it guarantees ‘Data Integrity,’ which encompasses completeness, accuracy, and consistency.

Along with this, SK Bioscience has also established a ‘Business Intelligence (BI)’ dashboard that analyzes the suitability of accumulated data and monitors the progress of trials 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, thereby enhancing both work efficiency and management systematization.

The clinical specimen analysis laboratory where SK Bioscience introduced this system was designated as an official clinical trial specimen analysis institution by the Korean Ministry of Food and Drug Safety in July 2019. In Korea, only institutions designated by the Ministry of Food and Drug Safety are strictly regulated to perform clinical trial specimen analysis according to safety-related regulations for pharmaceuticals and other products.

SK Bioscience plans to accelerate IT advancement for global expansion starting with this LIMS introduction. Recently, the U.S. Food and Drug Administration (FDA) has required the ‘FDA 21 CFR Part 11’ electronic record management regulation for raw materials and finished pharmaceutical products sold in the U.S., and it is expected that the competitiveness of products using LIMS and other systems will be further strengthened in the future.

Hwang Jae-seon, Head of Digital Innovation at SK Bioscience, said, “To enter advanced bio and vaccine markets such as Europe and the U.S., complying with global regulations and standards is of utmost importance,” adding, “Digital capabilities that meet global standards such as LIMS will play a crucial role not only in securing product competitiveness but also in collaborating with various overseas partners.”

This content was produced with the assistance of AI translation services.