FDA Guidance Answers Questions Regarding Data Integrity
by David Jensen, Marketing Communications Specialist, MasterControl

An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

FDA finds the increase of data integrity violations troubling. Nevertheless, the agency’s current position on the content of the guidance is that it should be viewed only as recommendations. The use of the word “should” in Agency guidances means that something is suggested, but not required.

Still, some of the “shoulds” addressed in the guidance might seem like a tall order for many regulated companies—particularly those using paper-based systems. FDA commonly encounters issues with the control of paper records, which can easily be discarded or lost. Other issues include an organisation’s handling of blank forms and conducting audit trails. This is where having an electronic quality management system (EQMS) can help organisations heed the suggestions in the guidance.

This article summarizes FDA’s responses to several of the questions raised about the guidance on data integrity and explains how an EQMS makes it easier to follow the suggested guidelines. For the full article,  click here.