Data Integrity and Regulatory Compliance
Data Integrity and Regulatory Compliance contains 2 topic pages in Pharmaceutical Quality Assurance.
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.
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Principles of Data Integrity
The ALCOA-Plus Framework The ALCOA-plus framework articulates the essential attributes that data must possess to be considered reliable and...
Computer System Validation and Electronic Records
Computer System Validation Computer system validation establishes documented evidence that a computerised system used to generate, process, or store...