CHAPTER 21: Quality Assurance Oversight for Data Integrity Check Access
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Published:06 Nov 2018
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Special Collection: 2018 ebook collection
Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories, The Royal Society of Chemistry, 2018, pp. 499-520.
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In Chapter 5 we discussed a data integrity model and one of the three areas emerging from the Foundation level was Quality Assurance oversight that was responsible for checks of current work, data integrity audits and data integrity investigations. This chapter will look at QA oversight in general and data integrity audits and Chapter 22 will focus on data integrity investigations. Quality Assurance oversight, can be defined as the process of keeping a process or initiative under observation to assure that it complies with applicable regulations and company procedures. The aim of QA oversight with respect to data integrity is independent assurance that procedures, processes and computerised systems are working compliantly and correctly for the generation of complete and accurate data and records. This chapter should be read in conjunction with Chapter 24 on a Data Integrity Audit Aide Memoire.