White Paper - Reap the benefits of AI in GxP environments with Joule

White Paper is addressing the GxP compliance requirements with detailed analysis to instill confidence in our Life Science Customers regarding application of our Joule application in the highly regulated GxP environments. Preuzmite dokument

Reap the benefits of AIin GxP environmentswith Joule
2 | 15Tableof contents4 Best practices for AI in GxPenvironments11 An introduction to Joule12 Using Joule in GxP environments15 AppendixAuthor: Santosh KulkarniContributors: Andreas Folz, Robert Geiger-Lebailly, and Prangya Pradhan
3 | 15Reap the benefits of AI in GxP environments with JouleGood industry practice (GxP) encompassesa set of quality guidelines and regulationsdesigned to help ensure that products aresafe, meet their intended use, and adhereto quality processes during manufacturing,control, storage, and distribution. Thiscomparative analysis illustrates how theJoule solution helps you adopt bestpractices based on both the ISPE’s GAMP® 5Appendix D11 risk framework1 and the ISO42001 standard for AI management systems.1. This industry-standard guidance is copyrighted by the International Society for Pharmaceutical Engineering.See the Appendix for details on the guidelines and regulations referred to in this document.