As the years passed, Emma's company became a leader in the industry, known for its commitment to quality and reliability. And Emma, the young quality assurance specialist, had become a respected expert in the field of GAMP.
It gives regulated industries a flexible, defensible, and efficient way to ensure that computers and software do not compromise product quality, patient safety, or data integrity. Whether you are validating a single pH meter or a multi-million dollar manufacturing line, GAMP provides the roadmap: Understand your risk, know your system category, follow the lifecycle, and prove it with traceable evidence. what is gamp
| Category | Description | Example | Validation Effort | |----------|-------------|---------|--------------------| | | Infrastructure software (OS, database engines, anti-virus) | Windows 11, SQL Server | Record version & configuration | | 3 | Non-configurable software (off-the-shelf, fixed function) | A simple digital thermometer | Moderate – test key functions | | 4 | Configurable software (user-modifiable settings) | ERP system, laboratory information system | High – test configuration & workflows | | 5 | Custom/bespoke software | In-house control code | Highest – full lifecycle validation | As the years passed, Emma's company became a