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Global Enforcement

  • They are watching.

    Computerized systems require an audit trail capability, meaning there is no place to hide when it comes to your data integrity requirements and validation protocol.

  • Sanctions are severe.

    Data integrity issues incur CGMP violations, FDA warning letters and legal actions that lead to FDA 483s and perhaps even warning letters.

  • Education not inspections.

    Federal mandates such as 21 CFR Part 11 regulatory compliance and CGMP guidelines require that you learn current policies for documenting, validating and archiving CGMP data.