SERVICES

• 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