1. Validation Copyright © 2004 Yokogawa Validation

2. Copyright © 2004 Yokogawa Page 2 Validation ProjectStandard Project > Validation

3. Validation Copyright © 2004 Yokogawa Page 3 > Validation Methodology Validation is a Methodology for... 4…establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specification and quality attributes.

4. Validation Copyright © 2004 Yokogawa Page 4 > Validation Master Plan Customer Begins Project Planning Customer’s Manufacturing Process is ‘Validated’ Validation Master Plan Chemistry (Process) Engineerg (Process ) Piping & Vessels Instrmnts & Control Packagin g / Storage Reporting & Storage QA Audits for Compl. Operation Managmn t Change Control Training Qualifictn Installat’ n Qualifictn Operation Qualifictn Perfrmnc Qualifictn 4 The Validation Master Plan ties separate parts of the project together.

5. Validation Copyright © 2004 Yokogawa Page 5 > Validation Master Plan 4Defines all Validation activities for the facility. Ties all Validation activities together. 4Identifies how the FDA Code of Federal Regulations (CFR) Parts 210 and 211 are applied to the facility. 4Identifies current Good Manufacturing Practices (cGMP) that are applied to the facility. 4Is developed by the customer. The customer has responsibility for Validation.

6. Validation Copyright © 2004 Yokogawa Page 6 > Project Quality Plan Project Planning Process is ‘Validated’ Validation Master Plan Yokogawa Project: 8Hardware 8Applications 8Qualifications

7. Validation Copyright © 2004 Yokogawa Page 7 > Differentiators Project Specific Quality Plan Anomaly Reporting System Phase Evaluation Reports Customer Approved Quality Gates Comprehensive Testing Quality Assurance Audits Personnel Qualifications Master Quality File Cautious Approach to Site Activities

8. Validation Copyright © 2004 Yokogawa Page 8 > Quality Plan Quality Barriers * For critical software. Required inputs are used all succeeding life-cycle phases: Required outputs are used as inputs by succeeding phases. SRS - System Requirements Spec. PQA - Project Quality Assurance PQP - Project Quality Plan FAT - Factory Acceptance Test SAT - Site Acceptance Test REQUIRED Q.A. TASKS REQUIRED Q.A. OUTPUTS CONCEPT PHASE 3.1.1 Concept Document Review 3.1.2 Functional Requirement Evaluation 3.1.3 Concept Phase Evaluation 3.0.1 Process Documentation 3.0.2 Construction Documentation 3.0.3 Development Schedule 3.0.4 Functional Requirements 3.2.1 Concept Phase Task Reports 3.2.2 Anomaly Summary Report 3.2.3 Concept Phase Summary Report REQUIRED Q.A. INPUTS 4.0.1 Standards 4.0.2 SRS 4.0.3 S/W Develpment Plan DESIGN PHASE 4.2.1 Design Phase Task Report 4.2.2 Anomaly Summary Report 4.2.3 Design Phase Summary Report 6.0.1 Hardware Test Plan & Report 6.0.2 Test Equipment Calibration 6.0.3 FAT Plan & Report FACTORY ACCEPTANCE TEST PHASE 6.1.1 Q.A. Witness of Hardware Test 6.1.2 PQA Audit Hdware Test Plan & Report 6.1.3 PQA Audit FAT Plan & Report 6.1.4 FAT Phase Evaluation 6.2.1 FAT Phase Task Report 6.2.2 H/W & FAT Audit Report 6.2.3 Anomaly Summary Report 6.2.4 FAT Phase Summary Report 5.0.1 Software Listings 5.0.2 Structural Testing Plan & Report IMPLEMENTATION PHASE 5.1.1 Software Listing Review 5.1.2 PQA. Audit - Structural Testing 5.1.3 Implementation Phase Evaluation 5.2.1 Structural Testing Audit Report 5.2.2 Implementation Phase Task Report 5.2.3 Anomaly Summary Report 5.2.4 Implementation Phase Summary Report 7.0.1 Test Equipment and Instrument Calibration 7.0.2 Continuity Verification 7.0.3 Installation Verification Test Plan 7.0.4 Loop Check SITE ACCEPTANCE TEST PHASE 7.1.1 SAT Phase Evaluation 7.2.1 SAT Phase Task Report 7.2.2 Anomaly Summary Report 7.2.3 SAT Phase Summary Report 4.1.1 Peer Review SRS 4.1.2 Peer Review S/W Devt.Plan 4.1.3 Design Phase Evaluation MANAGEMENT OF PROJECT QUALITY - PQP Generation- Management Review - Baseline Change Assessment - Review Support - PQP and Updates - Task Reports - Phase Summary Reports - Anomaly Report(s)

9. Validation Copyright © 2004 Yokogawa Page 9 > Why Yokogawa ? Yokogawa has a complete set of internal standards for all project phases Yokogawa complies with international standards Yokogawa is amenable to external compliance audits ISO 9001

10. Validation Copyright © 2004 Yokogawa Page 10 > Engineering Methodology Requirements Design Implementation Site Testing Factory Testing Quality Gates

11. Validation Copyright © 2004 Yokogawa Page 11 > Build Quality In... Avoid “Test Quality In”

12. Validation Copyright © 2004 Yokogawa Page 12 > Hit the Target Minimize Punch-list Items...

13. Validation Copyright © 2004 Yokogawa Page 13 > Test Protocols TEST PROTOCOL Protocol Objective Generate Protocol Review / Approve Execute Testing Generate Analysis & Conclusions Assemble into “Package” Review / Approve

14. Validation Copyright © 2004 Yokogawa Page 14 Hardware Plan/Protocol --- Component Tests --- Report QA Audit > Detailed Testing 4Detailed Test Documentation is Required!! Structural Plan Protocols Unit Tests Module Tests Integration Tests Report QA Audit Functional Plan Protocols Functional Tests --- Report QA Audit

15. Validation Copyright © 2004 Yokogawa Page 15 > Level of Effort Number of 2” Binders... Standard w/Seq’s Validation w/Seq’s Validation w/Batch Test Document Hardware Structural Functional TOTALS: 12251225 2 21 12 35 Sample Project Comparison: 2 5 4 11

16. Validation Copyright © 2004 Yokogawa Page 16 > Summary Yokogawa has the people equipped to perform validatable system projects Yokogawa has the methodology to perform validatable system projects –project management –engineering –hardware –software –applications Yokogawa has the experience to perform validatable system projects