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About CSV Gamp 5
GAMP5 defines categories and validation deliverables for computerized systems. Category 1 systems are infrastructure software, Category 3 are non-configurable, Category 4 are configurable, and Category 5 are customized applications. Validation deliverables include documents like initial risk assessments, user requirement specifications, functional specifications, installation qualification protocols and reports, operational qualification protocols and reports, and validation summary reports. These deliverables are mapped to different software categories to ensure computerized systems meet regulatory requirements and are fit for intended use.
Detailed Information
| Author: | ['Abdou Soudaki'] |
|---|---|
| Publication Year: | 2023 |
| Pages: | 37 |
| Language: | English |
| Format: | |
| Price: | FREE |
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