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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.

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Contact our dedicated support team for more information about our Data Integrity eLearning course and new Data Integrity Series focusing on GxP data integrity.