Project Details
As Requirements of GxP it is mandatory to Monitor clean rooms with compliance of standards CFR21 part11 & GAMP4, charts, trends, history, Data integrity, backup integrity, security levels, audit trails and other feature are already implemented in ME VAC BMS project with Schneider software & components ,
BMS Validation also was from our scope in this project starting from D.Q. (design qualification) & I.Q. (installation Qualification) and P.Q. (Performance Qualification as per standard WHO, CFR21 part11, GAMP5