Packaging Equipment & Process Support
Installation, optimization, and troubleshooting of bottle, blister, vial, and syringe lines.
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Process Optimization
Lean-based assessments to improve throughput and reduce changeover time.
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Equipment Selection & Specification
URS development, design specs, capital justification, FAT/SAT support, and more.
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Validation Services (IQ/OQ/PQ & CSV)
Equipment, utility, facility, and software qualifications following FDA & GAMP 5.
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Technical Documentation
SOPs for cleaning, operation, deviations, and preventive maintenance.
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Computer System Validation (CSV)
Validation planning and traceability tools for SCADA and instrumentation.
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Environmental Characterization
Cleanroom validation, HVAC testing, isolators, and air quality protocols.
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Control Systems & Automation
SCADA integration and instrumentation commissioning
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In-Plant Training
Customized training for operators, maintenance, and validation teams.
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Outsourced Technical Staffing
Expert staffing for QA/QC, validation, automation, project management, and more.
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