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This paper proposes a Retrospective Computerized System Validation (RCSV) method for Drug Manufacturing Software (DMSW) that relates to drug production considering software modification. Because DMSW that is used for quality management and facility control affects big impact to quality of drugs, regulatory agency required proofs of adequacy for DMSW’s functions and performance based on developed documents and test results. Especially, the work that explains adequacy for previously developed DMSW based on existing documents and operational records is called RCSV. When modifying RCSV conducted DMSW, it was difficult to secure consistency between developed documents and test results for modified DMSW parts and existing documents and operational records for non-modified DMSW parts. This made conducting RCSV difficult. In this paper, we proposed (a) definition of documents architecture, (b) definition of descriptive items and levels in the documents, (c) management of design information using database, (d) exhaustive testing, and (e) integrated RCSV procedure. As a result, we could conduct adequate RCSV securing consistency.

A Method of Retrospective Computerized System Validation for Drug Manufacturing Software Considering Modifications