Validation of ERP software and system architectures in a GxP controlled environment

Gaurav Pandey *

IEEE Senior Member (99404621), Cleveland (OH) chapter, Ohio, USA.
 
Review
International Journal of Science and Research Archive, 2024, 12(01), 413–416.
Article DOI: 10.30574/ijsra.2024.12.1.0828
Publication history: 
Received on 31 March 2024; revised on 08 May 2024; accepted on 10 May 2024
 
Abstract: 
ERP (Enterprise Resource Planning) is a software system which integrates all the business processes to run a company successfully. These software systems are widely used across all the industries like Manufacturing, Retail, Life Sciences, Banking and Finance etc. However, for pharmaceutical companies, the ERP systems must comply with GxP regulations which poses unique challenges. This whitepaper explores how to design and implement the software architecture of an ERP system in a GxP controlled environment.
 
Keywords: 
ERP Software; GxP Validation; ALCOA+
 
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