Project : Network Quailfication

Systems :

• Network Qualification & Backup System

Period : 2012.12 ~ 진행중

Project : Equipment Validation

Systems :

• DPS(Digital Picking System)
• 2D Barcode System

Period : 2012.11 ~ 진행중

Project : Equipment Quailfication Validation

Systems :

• 2D Barcode System

Period : 2012.12 ~ 진행중

Project : Equipment Quailfication Validation

Systems :

• 2D Barcode System

Period : 2012.12 ~ 진행중

Project : CSV Upgrade Project

Systems :

• ERP PM Module

Period : 2012.11 ~ 2013.01

Project : IT System Validation

Systems :

• LIMS / RWS

Period : 2012.01 ~ 2012.09

Project : CSV Upgrade Project

Systems :

• 각 Solution(All IT System) 및 Process

Period : 2012.02 ~ 진행중

Project : IT System Validation

Systems :

• ERP(SAP ERP MM/WM/QM Module CSV)

Period : 2012.03 ~ 진행중

Project : IT System Validation

Systems :

• PMS(Project Management System)

Period : 2012.04 ~ 2012.09

Project : IT System Validation

Systems :

• 1단계(CSV 정책수립 및 절차 / WMS / RWS)

Period : 2012.06 ~ 진행중

Project : IT System Validation

Systems :

• 실험장비 CSV 용역

Period : 2012.04 ~ 2012.09

Project : Equipment System Validation

Systems :

• Endotoxin Tester 3EA
• FACS(Fluorescence Activated Cell Sorter) 1EA

Period : 2012.08 ~ 2013.01

Project : 백암공장 증설공사 Validation Consulting

Systems :

• Equipment(50), HVAC, PWS, BMS, WMS
• [세파동(API), 완제동, Utility동, 자동창고 공통]

Period : 2011.06 ~ 2013.01

Project : Equipment Validation

Systems :

• 점도측정기

Period : 2011.06 ~ 2011.08

Project : Equipment & IT System Validation

Systems :

• Filling Machine & Facility of WMS

Period : 2011.07 ~ 2012.04

Project : IT System Validation

Systems :

• Warehouse Management System

Period : 2011.01 ~ 2011.07

Project : Equipment & IT System Validation

Systems :

• Conveyer & Facility of WMS

Period : 2011.04 ~ 2012.07

Project : IT System Assessment

Systems :

• All IT System

Period : 2011.08 ~ 2011.09

Project : IT System Validation

Systems :

• QMS(Quality Management System)

Period : 2011.09 ~ 2012.03

Project : Equipment Validation

Systems :

• Coating Machine

Period : 2011.09 ~ 2011.10

Project : IT System Validation

Systems :

• BMS Validation

Project : IT System Total Validation

Systems :

• ERP, MES, LIMS, WMS, APS, EDMS

Project : IT System Total Validation

Systems :

• ERP, LIMS, WMS, APS

Project : Equipment Qualification

Systems :

• Equipment CSV for 40EA
• 말라리아 site CSV 관리체계 확립

Project : Equipment Qualification

Systems :

• Equipment CSV for 20EA
• 실험실 장비 CSV

Project : Equipment Qualification

Systems :

• 수원/대소/이천 공장 Equipment CSV for 35EA

Project : IT System Total Validation

Systems :

• ERP, MES, LIMS, EDMS, WMS, AWS

Project : IT System Validation

Systems :

• Warehousing Management System Validation

Project : IT System Validation

Systems :

• Raw material Weighting System Validation

Project : IT System Validation

Systems :

• ERP System Concept Design
• ERP System Validation
• Raw material Weighting System Validation

Project : Equipment Qualification

Systems :

• Computer System Validation for HVAC Validation

Project : Equipment Qualification

Systems :

• Temperature Monitoring System

Project : Equipment Qualification

Systems :

• Retrospective Equipment Qualification

Project : IT System Validation

Systems :

• Laboratory Data Back System Validation

Project : IT System Validation

Systems :

• WMS Validation

Project : IT System Validation

Systems :

• ERP System Concept Design
• ERP System Validation

Project : IT System Validation

Systems :

• CSV for PTR Process Control System

Project : Equipment Qualification

Systems :

• Retrospective Equipment Qualification for 34EA
• Water System Validation(PW, WFI) Compress Air

Project : Prospective Equipment Qualification

Systems :

• Prospective Equipment Qualification

Project : Prospective Equipment Qualification

Systems :

• Prospective Equipment Qualification

Project : Prospective Equipment Qualification

Systems :

• Prospective Equipment Qualification for 34EA
• Equipment Validation for PW & WFI System

Project : Computer System Validation

Systems :

• Computer System Validation for HVAC

Project : Computer System Validation

Systems :

• Computer System Validation services for equipments Project Management for HVAC Validation

Project : Computer System Validation for WMS

Systems :

• Computer System Validation for WMS

Project : General Computer System Validation consulting and Computerized System Remediation project development

Systems :

• All computerized systems, including Automated Process Equipment, Utilities, Laboratory Equipment, LIMS, MCS, BMS, EAM, ERP, and Network

Activities:

• Validated Enterprise Asset Management (EAM) system
• Helped upgrade Change Control program
• Helped created an inventory of all Computerized Systems
• Developed the Remediation project
• Helped resolve audit observations
• Developed the Network Qualification project
• Conducted Gap Analysisof all systems for the Remediation project
• Helped upgrade the Calibration program
• Helped develop the Risk Assessment process
• Currently validating the LIMS

Project : Prepared validation protocolsfor Data Logger software

• eBro Winlog 2000 Data Logger software
• eBro Winlog Pharm Data Logger software

• Developed IQ/OQ protocols
• System review and compliance assessment

Project : Validation of Laboratory Information Management

• PharmMate LIMS (by Interface InfoTech)

• Developed a Validation Plan
• Conducted a Risk Assessment
• System review and compliance assessment
• Review and Update the URS, FS, and DS
• Developed IQ, OQ, and PQ

Project : Gap analysis of Tablet PressMachine

• Sejong MRC-36N Tablet Press System

• Reviewed company policies and procedures
• Developed questionnaire
• Collected information and reviewed documentation
• Wrote summary report of analysis with suggested remediation activities
• Wrote template for summary report
• Trained employees for conducting Gap Analysis on other systems

Project : General Computer System Validation consulting

• Computerized System Validation program
• DeLama Autoclave
• Delta V Manufacturing Control System (MCS)
• Honeywell Building Management System (BMS)

• Helped during client audit and recommended responsesfor audit observations
• Helped develop the Computerized SystemsValidation Master Plan
• Assessed the Autoclave for CSV and Part 11 compliance
• Helped develop OQ Addendum protocolsfor Delta V
• Helped resolve HVAC problem in the BMS

2004

Schering-Plough USA

Continuation of project from 2003

• General manufacturing automated equipment including: Orienters, Labelers, Cappers, Cartoners, SCADA, Label Vision Inspection system
• Tablet manufacturing automated equipment including: Tablet press, Tablet filler, Cottoners, Blister pack machines
• Liquid manufacturing equipment including: Checkweighers, Liquid fillers
• Dry Powder manufacturing automated equipment including: PCS, Verification system, Assembler, Heatsealer
• Aerosol manufacturing automated equipment including: Aerosol filler, Pressure verification system, Leak detection system, Checkweigher
• Bioreactor

• Project management
• Reviewed the URS, FRS, and DDS
• Wrote Validation Plans for each equipment
• Developed IQ, OQ, and PQ protocols
• Developed Retirement Plans, Retirement protocols, and Retirement summary reports
• Test execution
• Developed SOPs
• Wrote Validation Summary Reports
• Assisted in replacement system selection
• Part 11 Gap Analysis

• Honeywell TDC3000 DCS

• Developed questionnaire
• Collected information and reviewed documentation
• Wrote summary report of analysis with suggested remediation activities

• General manufacturing automated equipment including: Lifts, Labelers, Cappers, Label Vision Inspection system
• Tablet manufacturing automated equipment including: Blenders, Tablet press, Tablet filler, Blister pack machines
• Liquid manufacturing equipment: Holding/Mixing tanks, Agitators, Pumps, Liquid fillers

• Wrote Validation Plans for each system
• Reviewed the URS, FRS, and DDS
• Developed IQ, OQ, and PQ protocols
• Test execution
• Developed SOPs
• Wrote Validation Summary Report

• Web-based Clinical Trials Software

• Wrote the MVP
• Reviewed the URS, FRS, and DDS
• Developed operational test scripts and PQ protocol, including Part 11 testing
• Test execution
• Update system under change control Wrote Validation Summary Report

• Proprietary LIMS

• Wrote Master Validation Plan (MVP)
• Reviewed the URS, FRS, and DDS
• Developed IQ and operational test scripts
• Reviewed test results
• Wrote Validation Summary Report

• All automated manufacturing and lab equipment
• DCS
• Database Systems
• Enterprise Resource Planning (ERP) software - SAP

• Developed questionnaire
• Collected information for each system
• Wrote summary report of analysis, with risk ratings and recommended remediation activities

• Web-based Clinical Trials Software

• Reviewed the User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Detailed Design Specifications (DDS)
• Developed operational test scripts and PQ protocol, including 21 CFR Part 11: Electronic Records, Electronic Signatures (Part 11) testing
• Test execution
• Update system under change control

• Brevetti Liquid Vial Inspection System
• Gettinge Autoclave system
• Building Management System (BMS)
• Water For Injection (WFI) system
• Procal - calibration management software
• Yokogawa Distributed Control System (DCS)

• Reviewed existing URS, FRS, DDS, and validation documentation
• Validation using Knapp Set methodology
• Developed IQ, OQ, and PQ protocols
• Test execution
• Developed Standard Operating Procedures (SOP)
• Wrote Validation Summary Reports

• Clean-In-Place (CIP) and Sterilize-In-Place (SIP) skids using Allen-Bradley Programmable Logic Controllers (PLC)
• Process Control System (PCS) workstations using Wonderware Human Machine Interfaces (HMI)
• Supervisory Control And Data Acquisition (SCADA) system
• Product flow controllers
• Mixing tank controllers
• Storage tanks
• Piping

• Developed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol documents
• Test execution