CHAPTER 6: Roles and Responsibilities in a Data Governance Programme Check Access

Data governance to ensure GXP data integrity in laboratories requires a multi-layered approach that runs throughout a regulated organisation, as can be seen in Chapter 4. Although data governance features in many data integrity guidance documents from both regulators and industry, any approach taken should be business rather than regulatory driven. It is important to ensure the integrity and protection of records for reasons of intellectual property protection as well as supporting products already on the market. In this chapter we discuss the roles and responsibilities of all people involved in a data integrity and data governance programme within a regulated pharmaceutical organisation at both the corporate and laboratory levels.