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[Music] [Music] hi friends welcome to 21 CFR part 11 today after a long gap we are again in front of you with a new video which describes how a pharmaceutical software must be developed and how it must be documented those who have not subscribed to our YouTube channel we would like to request you that please subscribe our YouTube channel to get such updates and those who have followed our Facebook page we would like to thank them with heart because of your support we are growing so lets get started in this video we are going to see the regulatory requirements of both the european legislative authorities and the fda we are also going to see about the list of documents that must be compiled while developing a software and during the validation we are also going to discuss about the current trends of problems and these discussions will help you during the audits so let us move ahead with these topics planning the development of the software with your software vendor you will find that y