Whitepaper

4 Questions to ask about Your 21 CRF Part 11 Validation


Compliance impacts your organisation at three levels: employee, IT systems and records. The pressure is on to demonstrate how you control and record compliance training and procedures – through audits, system validations and e-signatures.

Non-compliance with the Food and Drug Administration (FDA) that mandates the authenticity of electronic records and signatures – including training records – has significant consequences.

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