Although knowledge of data integrity principles is considered to be well established throughout the entire pharmaceutical field, with a high level of awareness that the true focal point is on data itself, it is still very common that, when talking about Data Integrity (DI), the discussion is typically about computerized systems, with almost no reference to processes and data written or archived on paper such as forms, log books, batch records, and other types of physical records.
Such a mindset amplifies the risks of not meeting Data Integrity regulations and contributes to a wider gap between procedures and data integrity principles.