Secure Document Workflows in Drug Development
DA has increased scrutiny of the integrity of data generated by biopharmaceutical companies and their suppliers, focusing on analytical laboratory results, batch records, quality procedures, and other documentation related to the development, scale up, analysis, and manufacture of drug products. Threequarters of the warning letters issued by FDA’s Center for Drug Evaluation and Research between January 2015 and May 2016 cited data integrity issues noting problems with how data were recorded and authenticated. In April 2016, the agency issued a draft guidance on data integrity, Data Integrity and Compliance with CGMP, that included a section on electronic signatures for master production and control records.
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