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  • Quality Management System design and development

  • "Lean SOP” development

  • SOP gap assessments

  • Qualification, in-process, and for-cause audits

  • Computerized system qualification audits and 21 CFR Part 11 assessment

  •  Inspection readiness preparation, including

    • Gap assessments

    • Mock inspections

    • Storyboard development

    • Interviewee coaching

    • Inspection plan development

    • Situation room facilitation

  • Veeva QualityVault, QMS, and eTMF configuration and implementation

  • Non-conformance, fraud, and scientific misconduct investigations

  • Quality metrics design and reporting

  • Training development and delivery

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