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How to Audit the vendor of Software for Gxp Purpose

Ashish Gupta August 16, 2021

         




Regulatory Agencies, like the FDA and EudraLex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studies, and Blood Products – and include organizations that sell in both the US and International markets.

                                                      

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Ashish Gupta

Posted by Ashish Gupta

Mr. Ashish Gupta is a founder at Ugine Engineers. Blog mission is to help in providing learning and Implementation contents. Having 8 years of experience, He was responsible for Automation Projects & Maintenance for Pharmaceuticals manufacturing plants. He is expertise driving projects in various technology platform automation of process and he has instrumental knowledge in automation product integration or operation. His project includes a complete automation of pharmaceutical manufacturing plant. Having hands on experience in Siemens, Rockwell, Honeywell, ABB, Endress + Hauser, and Rosemount automation products. I hold a Bachelor of Engineering degree in Electronics & Communication from Government Engineering College Rewa Madhya Pradesh…

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