Do you have a strict changecontrolprocedure, which follows the requirements of the GMP Guidelines (revised in 2010)?
您是否建立了符合药品GMP（2010年修订）要求且很严格的变更控制程序？
2
What is the procedure for changecontrol system for the documentation?
文件变更控制体系程序是怎样的？
3
IT organizations must establish a specific changecontrol process for every type of change and consider a procedure specific to rapid and emergency changes.