Software developed internally or specifically for the company (bespoke) to fulfill unique business processes.
Not all software is created equal. Validating a simple spreadsheet requires much less documentation than validating a global Enterprise Resource Planning (ERP) system. By categorizing software, companies can: Focus efforts where the risk is highest. Reduce Costs: Avoid "over-validating" simple systems. gamp 5 categories
Category 5 covers Custom Software, designed and coded specifically for the user. This might include a bespoke manufacturing execution system or a unique algorithm developed in-house. Historically, Category 5 carried the highest risk due to the novelty of the code and the lack of widespread usage data. By categorizing software, companies can: Focus efforts where
Category 3 represents Standard Software Components, such as off-the-shelf commercial software like Microsoft Excel, statistical analysis tools, or standard LIMS (Laboratory Information Management Systems) modules. The defining characteristic of Category 3 is that it is used "out of the box" without configuration. This might include a bespoke manufacturing execution system