Validation & Technical Services Integrated Inc.


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Services
Validation & Technical Services Integrated, Inc. provides a wide variety of services. Listed below are selects of our offerings. If you do not see your need expressed, please contact us. There is every possibility that we may be of assistance. If we cannot assist, we can refer you to a group that can provide what you need.

     Quality Assurance Services
        * FDA Compliance Assessments & Assistance
        * Quality System Assessments
        * Procedure and Documentation Review
        * Master Batch Record Review
        * Supplier / Vendor Quality Program
        * Vendor Audits
        * GMP Training

      Validation Planning & Documentation
        * Validation Project Management
        * Validation Master Planning
        * Validation Protocol Preparation / Execution (IQ/OQ/PQ) / Summary Report
        * Validation Training / Consultation
        * Facility & Utility Systems Qualifications
        * Process Equipment Qualification
        * Computer & Controls Validation
        * Cleaning Validation
        * Process Validation
        * Test Methods Validation

     GMP & Regulatory Compliance
        * Assessment Of Current Levels Of GMP and Compliance to International Standards
        * Internal Audit Systems
        * GAP Analysis
        * Contract Manufacturer Audits
        * Regulatory Submissions (NDA, ANDA, DMF, PMA, etc)
        * Facility / System Design Review
        * Sterility Assurance Strategy

     Production & Process Engineering
        * Technology Analysis
        * Technology Transfer and Scale-ups
        * Process Design

     Design & Engineering Specifications
        * GMP / Process Assistance
        * Equipment Specification
        * Facility / Utility Design
        * Engineering Documentation System & Construction Review
        * Preventive Maintenance & Calibration Program
        * Change Control Management



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