Data integrity is an old concept made essential in today’s digital age, and means data that is accurate, complete, and repeatable, which in turn ensures the product’s quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters. The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug, and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.1 Production systems have large, inherent operational risks and are difficult to validate. Instead of exclusively reacting to public health disasters, preventative measures — such as the requirement for proof of claims — are taken to lower their likelihood and instill confidence in manufacturers. Click Here For Complete Abstract Text
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