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The term small-scale radiopharmacy is not related to the physical size of the facility, but only to the kind of radiopharmaceutical preparation performed.Another feature of validation is to produce an auditable system; having the appropriate documentation to aid any audit or inspection.The problem is how to respond to the requirement for computer validation. Equally important, is the fact that one organisation’s use of an application can be markedly different from another’s use of the same software.Establishing documented evidence which provides a high degree of assurance that a specific computer-related system will consistently produce a product meeting its predetermined specifications [PDA Technical Report 18, Validation of Computer-Related Systems, 1995].There are other regulatory or quality guidelines from the European Union and the Organisation for Economic Development.