Case Study: SELTA SQUARE achieves 4x faster pharmacovigilance and automated drug‑safety monitoring with IBM RPA

SELTA SQUARE automates a core process for drug safety monitoring using IBM RPA

SELTA SQUARE, a company launched with backing from Daewoong Pharmaceutical, set out to modernize pharmacovigilance (PV) — the legally required, labor‑intensive monitoring of adverse drug effects — which had required a full workday per product and manual handling of searches, screenshots and uploads. After an initial automation attempt with third‑party software produced incompatible Excel outputs and extra rework, SELTA SQUARE turned to IBM and its IBM RPA technology to build a reliable, scalable PV solution.

Working with IBM, SELTA SQUARE replaced the flawed tool with IBM RPA, moved the service to the web as Korea’s first PV‑as‑a‑service, and validated data via computerized system validation to meet FDA21 CFR Part 11 and ISPE GAMP 5 guidelines. The combined IBM RPA and SELTA SQUARE AI solution now runs 24/7, reduces average search time from about 5 minutes to 1 minute 11 seconds (>4× faster), eliminates data‑incompatibility issues, and frees experts to focus on higher‑value review and analysis.

SELTA SQUARE

Min Kyung Shin

Chief Executive Officer