Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
CHAPTER 7: Ensuring Data Integrity for Chromatography Data Systems
Published:23 Nov 2016
At the time of writing this chapter, data integrity is the hottest topic in the pharmaceutical and allied industries globally. Given the number of data integrity guidance documents already published and those due to be published in 2016–2017, this will continue to be a major regulatory topic for some time to come. Chromatography Data Systems (CDS) have had a starring role in many regulatory citations involving falsification and fraud as well as poor data management practices in regulated GXP laboratories since 2005. In this chapter, we will consider a holistic approach to data integrity by looking at the regulatory guidance on the subject, develop a data integrity model, examine data governance and identify the technical and procedural controls required to ensure data integrity within these systems. It is important to realise that data integrity is a far more encompassing subject than just ensuring that the numbers generated by a CDS are correct.