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Jean-Louis BODREN is head of Syentys SA with an important experience of software validation in the pharmaceutical industry. Vincent LAURENT is head of LogicaSoft and has a long experience in science related projects.
Although Odoo is a powerful ERP that offers a wide coverage of functions, implementing it within the pharmaceutical industry requires adhering to very specific rules (GxP) and complying with specific requirements. This presentation focuses on the implementation of Odoo in the highly regulated pharmaceutical industry.
Every software solution which applies to production within this industry, must be defined, developed and validated against extremely stringent norms called GxP series, and especially CFR 21 Part 11 (code of federal regulation from the food and drug administration). These regulations were always considered as a major blocking situation for Odoo within the pharmaceutical industry, but we believe that since Odoo v11, these regulations can be met by Odoo.
The main purpose of this talk is to demonstrate that Odoo is GxP capable and can comply with the very specific requirements of the CFR 21 part 11.