VDI/VDE 3516 Blatt 2:2013-11

The scope of this standard is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 and to provide guidance on a pragmatic validation approach for small manufacturing and testing devices. Examples of small devices in discussion are, to name only few: pH meters, balances, digital controlled equipment, PLC controlled equipment, electronic recorders, optical sensor instruments and measuring transducers. All of the above examples are inclusive parameters. Medical devices are not within the scope of this standard.