Quality Considerations for a Robust Data Integrity Program

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Accurate and complete data gives us confidence in product safety and quality, so data integrity demands a great deal of attention in the life science industry. This is truer than ever with increased focus from the FDA, EU, and industry standards on data integrity issues and best practices. Guidance seeks to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, in response to an increase in data integrity lapses in recent inspections. Data integrity procedures and programs alone are not sufficient: they must be part of larger data governance framework.

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