CHAPTER 3: The Regulators' Responses Check Access

In response to data integrity issues, regulatory authorities have issued guidance documents covering data integrity, good record keeping practices, good data management practices and data integrity and compliance with GMP regulations. There have always been requirements for data integrity within all GXP regulations but often these are implicit. As regulations are updated, then more data integrity requirements are incorporated into the regulations such as EU GMP Chapter 1 on Pharmaceutical Quality Systems and Annex 11 on Computerised Systems. Additionally, the GAMP Forum has issued a Guide entitled Records and Data Integrity that provides more information about data governance and data integrity than contained in the regulatory guidance documents. Lastly, there is a discussion of what records constitute raw data and can raw data and complete data be considered the same?