Compliance with 21 CFR Part 11 is an important aspect of ensuring electronic data integrity. Starting with an audit or gap analysis, Globiox can develop strategies for compliance for electronic and hybrid systems. Globiox has experience in finding those areas where data integrity breaks down, which is common when data is transmitted between applications, between companies, or from an instrument to a spreadsheet or database. Our services include:

  • Data integrity audit
  • Data integrity issue remediation
  • 21 CFR Part 11 assessment
  • Develop 21 CFR Part 11 compliance strategies