01
Preventing Investment Budget Waste (ISMP)
System introduction without prior analysis
of actual laboratory workflows carries high risks. We pre-screen budget waste factors by thoroughly
verifying the User Requirement Specifications (URS) optimized for the client's business goals.
02
Global Regulatory Compliance Protection
(CSV)
We clearly defend against regulatory
barriers critical to biotech companies, such as MFDS audits, FDA 21 CFR Part 11, and cGMP
certification. We establish and execute Standard Operating Procedures (SOPs) spanning from
individual equipment Computer System Validation (CSV) to enterprise-wide laboratory Data Integrity
(DI).
03
Designing Artificial Intelligence (AI)
Roadmaps
Going beyond simple paperless data
accumulation, we design long-term data pre-processing structures and convergence roadmaps to
seamlessly combine collected raw data and LIMS data with AI analysis and visualization models.
04
Data Integrity (DI) Risk Assessment
We pre-screen whether the creation,
modification, and deletion histories (Audit Trail) of laboratory data meet the audit criteria of
global regulatory agencies, and present system remedies to inherently block data manipulation risks.
05
Integrating Heterogeneous Instruments &
Systems
We establish integrated architecture
guidelines that smoothly connect data workflows between various analytical instruments in the
laboratory (networked and standalone) and existing enterprise systems like ERP and MES without
bottlenecks.
06
Requirement Verification & Solution Vendor
Evaluation
We objectively evaluate whether the
technologies proposed by numerous solution vendors fit your research center. By thoroughly reviewing
the supplier's technical limitations, we prevent risks of toxic clauses or missing features during
contract signing.
