VDI/VDE 3516 Blatt 2:2012-07

The scope of this guideline is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 in regard to small devices by considering possible risks, efficiency and the sense and purpose of 21 CFR Part 11 and to provide guidance on a pragmatic validation approach for small manufacturing and testing devices. To attain this goal, we will define and divide small devices in device classes. These classes will then be mirrored against the requirements of 21 CFR Part 11. 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. Devices with data handling and transmission in analog fashion do not have to be viewed in regard to 21 CFR Part 11. Medical devices are not within the scope of this guideline because they are impacted by other rules (e.g. FDA 21 CFR 820, Medical Devices). The ""Guidance for Industry: Part 11, Electronic Records; Electronic Signatures Scope and Application"", issued Aug. 28th, 2003, and its narrower definition of electronic records are also a basis for this guideline.