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  • Project Initiation and Planning

  • System Development and Verification
  • System Requirements and Design

  • Computer System Validation

  • System Type Expertise:

    • Quality Document Management Systems and Workflows

    • Learning Management Systems

    • Change Control Systems

    • Manufacturing Process Control Systems

    • Manufacturing Execution Systems

    • Laboratory Data Acquisition and Information Systems

  • Validation Strategy and Plan

  • Risk Analysis

  • Infrastructure Qualification

  • Qualification Plans for all Phases of a Life Cycle: IQ, OQ, PQ

  • Execution of Qualification Plans

  • Preparation of Qualification Reports

  • Preparation of GMP Documentation

  • Re-qualification and Periodic Review

  • Establishing Change Control Processes

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