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  • About U.S. Validation Services, LLC

    Validation Services
    With more than 30 years of industry experience, we excel in delivering pragmatic and budget-friendly solutions that guarantee the validation of your facilities, utility systems, computerized systems, software, and equipment, all while enhancing FDA compliance.
    Our seasoned team, with expertise in GMP-regulated industries, will guide you through the validation process for your facilities, utility systems, and equipment

  • Validation Planing And Management

    • Validation Program Auditing and Optimization
    • Policy and Procedure Development
    • Validation Master Plan Preparation
    • Project Management
    • Protocol Preparation (IQ,OQ, PQ)
    • Deviation Resolution - Corrective and Preventive Action (CAPA)

  • Equipment, Facility, and Utility Systems Validation

    • Compliance Assessments
    • Validation Master Plan Development
    • Validation Project Management
    • Development of Quality System documentation (Plans, SOPs, Protocols, Schedules, Reports etc)
    • Factory Acceptance Testing (FAT)
    • Site Acceptance Testing (SAT)
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • GAP Analysis and Remediation
    • Risk Analysis

  • Computerized Systems Validation

    • Software Vendor Audits
    • Validation Master Planning
    • User Requirements Specifications (Business Requirements)
    • Validation Protocols
    • Functional Specifications

  • CFR 21, Part 11 Electronic Records and Electronic Signatures

    • Assessment
    • Remediation Plan

  • Calibration Program Management

    • Metrology Program Auditing and Optimization
    • Metrology Policy Review and Preparation
    • Calibration/Re-calibration Procedures Review and Preparation
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Phone: 561-299-0095 15418 Fiorenza Cir. Delray Beach, FL 33446