1. Capital Waste Prevention (ISMP)
System integration without prior workflow analysis carries high risks. I pre-screen budget
inefficiencies by meticulously validating User Requirement Specifications (URS) tailored to your
business goals.
2. Global Regulatory Defense (CSV)
Defend against critical regulatory hurdles including FDA 21 CFR Part 11, cGMP, and MFDS audits. I
guide the formulation of Standard Operating Procedures (SOP) for robust Computer System Validation
(CSV).
3. Lab Artificial Intelligence (AI) Roadmap
Moving beyond paperless data accumulation, I design long-term data pre-processing architectures to
seamlessly combine raw laboratory data with advanced AI analytics and visualization models.
4. Data Integrity (DI) Risk Assessment
Pre-screen whether data modification and generation logs (Audit Trail) comply with global agency
standards, providing strategic system controls to proactively prevent data manipulation risks.
5. Heterogeneous Equipment Integration
Establish unified architectural guidelines that flawlessly bridge data flows between various
analytical instruments (networked & standalone) and enterprise systems like ERP or MES.
6. Korea Market Entry & Localization
I support global informatics vendors entering the South Korean market. Align your solution with
Korea’s unique bio-pharma infrastructure, local compliance standards, and custom regulatory
frameworks (e.g., KOLAS / ISO 17025).
