QA Audit Preparation and Response

  • Assist QA Department with preparation for an audit conducted by clientele or an inspection being conducted by a regulatory body
    • Document and Data Review
    • Conduct internal process audits to detect and correct non-compliance
    • SOP writing
  • Assist QA and operations staff in resolving Quality issues and develop action plans to correct deficiencies
    • Assist QA with Audit Responses
    • Assist with Part 11 Remediation and Compliance
    • Qualify Excel Spreadsheets:  Microsoft Excel is not Part 11 compliant. However, there are security and protective measures that can be implemented to decrease risk.
  • Conduct Vendor Qualification and Maintenance Audits