Gamp 5 Categories With Examples
Configuring a clinical trial database with specific fields and validations. Category 5: Custom Applications
Using Excel for simple data entry (not complex macros). Statistical Tools: Standard versions of Minitab or SPSS. Category 4: Configured Products
This is the most common category in the Life Sciences. These systems provide standard functions, but they allow the user to configure specific workflows, data structures, or business rules without changing the underlying software code.
Custom PLC (Programmable Logic Controller) code for a unique assembly line robot. Summary Table: Effort vs. Category Risk Level Primary Validation Focus Cat 1 Infrastructure Installation Qualification (IQ) Cat 3 Non-Configured Low/Medium URS & Operational Testing Cat 4 Configured Medium/High Configuration Specs & Risk Assessment Cat 5 Code Review, Design Specs, Full Testing Why Categorization Matters gamp 5 categories with examples
A core pillar of GAMP 5 is the classification of software into . These categories help quality and engineering teams decide how much validation effort is required. The logic is simple: the more complex and "custom" a system is, the higher the risk, and the more testing you need to do.
High confidence in the vendor; the software is used for its intended purpose without modification.
These are systems built from scratch or contain custom-coded modules to meet unique business needs. This category carries the highest risk because the "code" is unique to your company. Configuring a clinical trial database with specific fields
A workbook using intricate VBA macros to calculate drug dosages.
Standard, off-the-shelf software that is used "out of the box." No configuration of the software itself is possible or allowed. Validation focuses on user requirements and testing of standard functions. Examples:
Note: In the transition from GAMP 4 to GAMP 5, Category 2 (Firmware) was removed. Most items previously in this category were moved to Category 3 or 4. Category 3: Non-Configured Products Category 4: Configured Products This is the most
Software for a simple pH meter or a digital scale.
A custom-coded portal that pulls data from five different legacy systems.
The full lifecycle is required. This includes formal Design Specifications, Code Reviews, Unit Testing, and rigorous Functional/User Acceptance Testing. Examples:
