Establishment And Implementation Of The Project Of Using QR Code For GMP Documentation Electronic Management System

With the development of time,progress of science and technology,documentation has become an essential part of information resources.It can be used for investigation,circumstantial evidence,scientific research and.historical retrospection.Traditional documentation management can not be adapted to the development of computer network information currently.The informatization of documentation management has become the trend of new situation.Documentation as the "software" in GMP system has been assurance of GMP quality system.The standard management of the GMP documentation is the premise of a standardization management for production process in pharmaceutical enterprise.This thesis starts from the practical problems of pharmaceutical company.It uses the method of 6 Sigma to research and optimize GMP documentation,carries out barcode GMP documentation electronic management system project according to chapter 8 of GMP,combining with the EU GMP,the chapter 21 of federal regulations(FDA 21 CFR Part 11)regulatory requirements.Build new GMP documentation management system,including written and accurate quality standard,prescription process,instructions,procedures and records,the process of creation,revision,review,approval,distribution,archiving,borrowing and expiration.For quality control part,this thesis adopts DMAIC model based on the core idea of 6 Sigma management,the project continuously improves product quality.The topic not only makes great sense to improve GMP documentation management,but also has been of great value to the modernization of documentation management in other industries.