F01
Conception
Feasibility
Strategy
Comparative Analysis
Acceptance
Conception
Feasibility
Strategy
Comparative Analysis
Acceptance
Definition
Planning
Design
Documentation
Analysis
Implementation
Acquisition
Supply
Construction
Evaluation
Operation
Documentation
Commissioning
Verification
Delivery
Deactivation
Transfer
Transition
Release
Closure
F01 | F02 | F03 | F04 | F05 |
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[ED]
Engineering Design |
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Concept Engineering | • | |||||
Basic Engineering | • | |||||
Detail Engineering | • | |||||
Technical Specification for Tenders | • | |||||
Re-Engineering |
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[PM]
Project Management |
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Project Coordination | • | • | ||||
Project Management | • | • | • |
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[QS]
Quality Scrutineering Tests |
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Comissioning | • | • | • | |||
Factory Acceptance Tests (FAT) | • | |||||
Start-Up Tests (CT / VT) | • | |||||
On-Site Acceptance Testing (SAT) | • | |||||
Qualifications (Q) | • | • | • | |||
Design Tests (DQ) | • | |||||
Installation / Operational Tests (IQ / OQ) | • | |||||
Functional Tests (PQ) | • | |||||
Validations (V) | • | • | • | |||
Calibrations | • | • | ||||
Clean Rooms / Environmental Conditions Tests | • | • | • | |||
Quality For Pharmaceutical Water Tests | • | • | ||||
Trainings | • | |||||
Re-Verifications |
F01 | F02 | F03 | F04 | F05 |
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[ED]
Engineering Design |
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Technical Feasibility Studies | • | • | ||||
Comparative Technical Studies | • | • | ||||
Engineering Design Review | • | • |
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[PM]
Project Management |
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Assistance to Project Management | • | • | • | • | • | |
Comparative Analysis of Suppliers | • | • |
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[QS]
Quality Scrutineering Tests |
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Verification Strategy | • | |||||
Impact Evaluation | • | |||||
Technical Scrutineering Plan | • | |||||
User Requirements | • | • | ||||
Risk Assessment and Analysis | • | • | ||||
Traceability Matrix Specifications | • | |||||
Acceptance Test Evaluation | • | • | ||||
Supervision Scrutineering Tests | • | • | • |
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[ED]
Enginnering Design |
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Expert in Engineering Design | |
Process Engineering | |
Clean Room Engineer | |
GxP Services Engineer | |
Non-GxP Services Engineer | |
Draftsman |
|
[PM]
Project Management |
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Engineering Project Manager | |
Construction Project Manager | |
Scrutineering Project Manager |
|
[QS]
Quality Scrutineering Tests |
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Expert in Quality Scrutineering Tests | |
CQV Engineer | |
CQV Technician | |
Technical Advisor to QA / QC / QV | |
Assistant to QA / QC / QV |