GAMP category 3 systems are considered critical systems that have a direct impact on product quality, patient safety, and data integrity. These systems are typically involved in controlling, monitoring, or recording critical process parameters, and their failure could result in product recalls, regulatory actions, or even harm to patients.
GAMP 5 (the current version) categorizes software into (1, 3, 4, 5) based on risk and complexity. Category 3 = Non-Configurable Software (sometimes called “off-the-shelf software with no configuration”). gamp category 3