Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes Part 2 - Risk to Records

Introduction Risk Assessment is a vital component in determining the appropriate validation and data integrity for automated systems used in supporting pharmaceutical and healthcare processes. Risk is considered in this article in terms of the impact an automated system can have on public health. The underlying assumption is that validation and data integrity controls should be established to commensurate with risk. Although the philosophy is not new, it has found recent prominence in relation to the FDA’s current Good Manufacturing Practice (GMP) review in relation to electronic records/signatures.1,2 This article sets out to demonstrate how the GAMP 43 risk analysis guidance can be applied in relation to these topics in the context of the GMPs and Good Distribution Practices (GDPs).1,4 This article begins by explaining how regulatory documents can be used to identify electronic records, goes on to discuss the impact