Gamp 5 Software Categories High Quality 【EXTENDED 2027】

| Misclassification | Reality | Fix | |--------------------------------------|------------------------------|----------------------------------------| | LIMS workflow configuration = Cat 3 | Cat 4 | Add configuration testing | | Simple script = Cat 4 | Cat 5 | Add code review + unit tests | | SaaS eQMS with no config = Cat 1 | Cat 3 (or 4 if configurable) | Assess actual use, not deployment type | | Firmware = Category 2 (old) | Cat 1 or 3 | Map to current guidance |

COTS (Commercial Off-The-Shelf) tools for document viewing. gamp 5 software categories

In recent years, the GAMP community has recognized that the lines between categories were blurring. How do you categorize a SaaS (Software as a Service) platform? How do you categorize an Excel spreadsheet that acts like a complex application? How do you categorize an Excel spreadsheet that

ERP systems (SAP), LIMS (Laboratory Information Management Systems), and Electronic Quality Management Systems (eQMS). Excel with simple formulas used for GxP calculation

Excel with no macros = Category 3. Excel with simple formulas used for GxP calculation = Category 4 (if controlled via input cells). Excel with VBA macro that automates data transfer = Category 5.