First among South Korea’s clinical trial sample analysis institutions, SK bioscience implements a Laboratory Information Management System(LIMS), advancing its processes with data integrity
SK bioscience, an innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the company which had acquired ‘Good Clinical Laboratory Practice (GCLP)’ in South Korea has implemented a Laboratory Information Management System(LIMS).’
SK bioscience completed the system construction and computer system validation (CSV) process begun in June last year and applied a LIMS to its own clinical trials starting on the 20th.
Based on ‘BIOVIA ONE LAB’ platform, a LIMS can track and manage all processes from simple receipt to analysis, storage, and export in real-time. Unlike manual methods, the system can guarantee data integrity encompassing completeness, accuracy, and consistency.
With LIMS, SK bioscience also established a ‘Business Intelligence(BI)’ dashboard that can analyze the suitability of accumulated data and monitor test progress in real time. Through the system, all immunogenicity analysis processes and results are recorded in real time, and the reports are automatically created, thereby strengthening work efficiency and management systematicity at the same time.
SK bioscience plans to further accelerate IT advancement, starting with the implementation of LIMS. Recently, the FDA is requiring ‘FDA 21 CFR Part 11’, an electronic record management regulation, for pharmaceutical raw materials and drug products sold in the United States, so the competitiveness of products managed with LIMS will be further strengthened in the future.
Jaesun Hwang, Head of the Digital Innovation department, SK bioscience said, “Complying with global regulations and standards is the most important factor in order to advance into vaccine markets in Europe and the United States. Digital capabilities that meet global standards such as implementing a LIMS will play an important role in securing product competitiveness and collaborating with various overseas partners.”