FDA published a guidance for Data Integrity and Compliance with CGMP, which answers data integrity questions in the hope of clarifying what FDA expects from manufacturers in order to reduce the amount of violations of data integrity.
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. Please read here the full article.