GAMP 5 approach for building GXP application

In the highly regulated world of pharmaceuticals and medical devices, ensuring the quality and integrity of data is paramount. This is where GxP (Good x Practice) regulations come in, dictating strict guidelines for how computerized systems are designed, developed, and maintained. For companies building GxP applications (GXP applications), the ISPE GAMP 5 (Good Automated Manufacturing …

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