FST provides
experienced, trained manpower and state-of-the-art equipment
to meet customer quality assurance objectives while satisfying
internal specifications and procedures and the site-specific
cGMP compliance program to meet FDA standards for validation.
Our bio-pharm services include:
Consulting
Project
Management
Inspection
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Specification review
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Installation drawings review
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Construction materials review
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Installation procedures generation or review
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Installation protocols generation or review
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cGMP compliance
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Visual acceptance stds
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Testing criteria & acceptance
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Hazardous materials
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Manpower & equipment utilization
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Schedule planning
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Contingency planning
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Risk assessments
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High return QA/QC activities
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Budget and cost control
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Safety execution and performance
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Material supplier audits
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Source inspections
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FATS and SATS
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Prefab verification
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Cleanroom certification
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Welder qualification
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Weld inspections
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Borescope inspections
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Slope verification
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NDE
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Remediation oversight
Training
Testing
Documentation Control
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cGMP compliance program
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Gas/liquid acceptance testing
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Installed process water systems
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> TOC analysis
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> Resistivity
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> Particles
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Radiographic testing
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Lab analysis interpretation
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Testing value assessments
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Material Control – at source, on site receiving
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Reports, logs, ISO drawings, for cGMP compliance
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Cleaning/Passivation documentation
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Turnover package
For More information, please call (512) 848-5677
FST US Operations
3500 Comsouth Drive
Austin, TX 78744
