Software Validation Gamp 5. An automated GAMP 5 system reduces audit time and findings and a decreases risk of product recalls. GAMP quickly became influential throughout Europe as the quality of its work was recognized internationally.
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GAMP 5 ISPE can be regarded as a structured approach for the validation of automated systems. As a result of this GAMP Category 4 software can require a much higher level of validation than GAMP Category 3. Over time GAMP has become the acknowledged expert body for addressing issues of computer system validation.
GAMP 5 and IEC 62304 adopt similar approaches to achieve a compliant structure for software to safeguard patients.
Compliant GxP Computerized Systems. The GAMP Guideline for Computer System Validation. Category 1 Infrastructure software including operating systems Database Managers etc. GAMP Software Category 5 Bespoke software is software that is generally written from scratch to fulfil the business need.
