About ATUSA LLC
ATUSA LLC provides validation services and defect sample set fabrication for the FDA-regulated industry, with over 40 years of combined experience in pharmaceutical inspection systems and validation processes.
Validation services for manufacturing and packaging equipmentPharmaceutical inspection systems validation for particle and cosmetic defectsFabrication of cosmetic and particulate test standards (defect sample sets)Functional Requirements, Systems Specifications, Validation Master Plan, Factory Acceptance Tests, Commissioning, Traceability Matrix, Site Acceptance Tests, Installation Operation, and Performance QualificationCleaning validation and Computer Systems validation (21 CFR Part 11)Inspector training and Manual Inspection for determination of Rejection Probability using Knapp approachSmoke Profile Testing for clean rooms and Particulate Monitoring for area classificationProduct Technology Transfer and Quality investigations
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