With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.
The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records. It also includes recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records are monitored, and can only be used by authorized personnel.