![]() This discussion focuses on commercially available software, or GAMP software categories 3 and 4 (5,6). Therefore, the work that a laboratory needs to perform will increase with the increasing complexity of the software (5). ![]() custom software and modules (category 5).Ī justified and documented risk assessment is the key to ensuring that the validation work can be defended in an inspection or audit.commercially available configured product (category 4).commercially available nonconfigured product (category 3).In essence, application software can be classified into one of three software categories using the approach described in the ISPE's Good Automated Manufacturing Practice (GAMP) Guidelines, version 5 ("GAMP 5") (4): The extent of work undertaken on each system depends on the nature of the software used to automate the process and the impact that the records generated by it have (1–3). Validation of computerized systems requires that a regulated organization working under good laboratory practice (GLP) or good manufacturing practice (GMP) requirements implement or develop a system that follows a predefined life cycle and generates documented evidence of the work performed. But we should ask two questions: Is OQ really essential to a validation project for this type of software such as a chromatography data system (CDS)? How much value does a software OQ for commercially available software actually provide to a validation project? Software operational qualification (OQ) is considered a mandatory item in a computerized system validation project for a regulated laboratory.
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