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기간 회사명 프 로 젝 트 내 역
2012

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

2011

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

2010

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
2009

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
2008

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
2007

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
2006

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

Systems
  • eBro Winlog 2000 Data Logger software
  • eBro Winlog Pharm Data Logger software
Activities
  • Developed IQ/OQ protocols
  • System review and compliance assessment
2005

(contract with Interface InfoTech Co. Ltd.)

Project : Validation of Laboratory Information Management

System

  • PharmMate LIMS (by Interface InfoTech)
Activities:
  • 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

Systems

  • Sejong MRC-36N Tablet Press System
Activities:
  • 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

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

2003 Perrigo Company Continuation of project from 2003
Schering-Plough USA Project : Retrospective validation of existing equipment
     Remediation activities resulting from Consent Decree
     from FDA

Systems:
  • 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
Activities:
  • 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
2002 Project : Gap analysis of DCS for validation and Part 11

Systems:
  • Honeywell TDC3000 DCS
Activities:
  • Developed questionnaire
  • Collected information and reviewed documentation
  • Wrote summary report of analysis with suggested remediation activities
Perrigo Company Project : Retrospective validation of existing equipment

Systems:
  • 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
Activities:
  • 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
2001 Research Scientists, Inc. Project : Validation of a web-based Clinical Trials Software

Systems:
  • Web-based Clinical Trials Software
Activities:
  • 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
Project : Validation of Laboratory Information Management System (LIMS)

Systems:
  • Proprietary LIMS
Activities:
  • Wrote Master Validation Plan (MVP)
  • Reviewed the URS, FRS, and DDS
  • Developed IQ and operational test scripts
  • Reviewed test results
  • Wrote Validation Summary Report
Aventis USA Project : Part 11 Gap Analysis

Systems:
  • All automated manufacturing and lab equipment
  • DCS
  • Database Systems
  • Enterprise Resource Planning (ERP) software - SAP
Activities:
  • Developed questionnaire
  • Collected information for each system
  • Wrote summary report of analysis, with risk ratings and recommended remediation activities
2000 Enmed Project : Validation of a web-based Clinical Trials Software

Systems:
  • Web-based Clinical Trials Software
Activities:
  • 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
Aventis USA Project : Retrospective validation of existing equipment

Systems:
  • 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)
Activities:
  • 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
1999 Centocor, Inc. Project : Validation for facility startup for Remicade

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


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