Our facility remediation work targets three core domains—each with overlapping risks and dependencies. We help you restore and maintain compliance across all of them.
Infrastructure & Environment
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Cleanroom classification and compliance
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HVAC and utility qualification (HEPA, pressure differentials, filtration, etc.)
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Temperature, humidity, and differential pressure control
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Facility layout redesign for flow, segregation, and cleaning access
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Construction and renovation oversight for GMP compliance
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Pest control and contamination prevention strategies
Equipment & Operational Systems
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Equipment qualification and validation (IQ/OQ/PQ)
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Calibration and preventive maintenance program overhaul
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Environmental monitoring program remediation
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Utility system validation (compressed air, purified water, etc.)
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Cleaning validation and procedural integration
People, Process & Oversight
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Material and personnel flow optimization
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SOPs for gowning, cleaning, monitoring, and excursion response
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Training and behavioral reinforcement to prevent recurrence
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Interim control strategies to maintain operations during remediation
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Integration with CAPA and change control systems
