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  • About U.S. Validation Services LLC

    Validation Services
    With over of 15 years of experience in the industry, we specialize in providing practical and cost-effective solutions which make your facility, utility systems, computerized systems, software, and equipment be in validated state while maintaining and improving FDA compliance. Our experienced in the GMP regulated industries team will help you to validate your Facility, Utility Systems and Equipment.

  • 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
    • Identify potential failure scenarios
    • Estimate the likelihood of these failures
    • Evaluate the severity of each potential risks
    • Development of Risk Based Impact Assessment

  • Computerized Systems Validation

    • Enterprise Level Software Qualification (LIMS, ERP, MES systems etc) qualification
    • Automated and Control Systems Qualification (DCS, SCADA, PLCs, BMS etc)
    • Infrastructure Qualification
    • Servers Qualification
    • Software Vendor Audits
    • Validation Master Planning
    • User Requirements Specifications (Business Requirements)
    • System and Component Impact Assessments
    • Functional Specifications
    • Design Requirements
    • Hardware and Software Development Life Cycle

  • CFR 21, Part 11 Electronic Records and Electronic Signatures

    • Assessment
    • Remediation Plan

  • Validation Planing And Management

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

  • 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: 617-306-6767 15418 Fiorenza Cir. Delray Beach, FL 33446