
FDA Releases Data Integrity Guidance
The agency published guidance on data integrity as it is relates to CGMP compliance.
On April 14, 2016, FDA published
The guidance states that data should be reliable and accurate, and companies should implement effective strategies to manage data integrity risks. Along with clarifying the definition of data integrity terms, the guidance addresses the exclusion of CGMP data, workflow validation, data access, audits, electronic records, and personnel training. FDA also clarifies sampling and testing requirements and how to address data integrity problems.
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