Data Integrity and Regulatory Compliance
Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle, and has become one of the most heavily scrutinised areas of pharmaceutical quality assurance following a marked increase in regulatory findings related to data manipulation and falsification. This chapter examines the ALCOA-plus framework that defines data integrity expectations, the principles of computer system validation and audit trail review, and the electronic records requirements established under United States regulation Title 21 Code of Federal Regulations Part 11.
Chapter overview
The ALCOA-plus framework governing data integrity, together with computer system validation, audit trail review, and electronic records requirements under 21 CFR Part 11.
