VDI/VDE 3516 BLATT 2
Validation in the GxP area - Small manufacturing and testing devices
| Organization: | VDI |
| Publication Date: | 1 November 2013 |
| Status: | active |
| Page Count: | 72 |
| ICS Code (Industrial process measurement and control): | 25.040.40 |
scope:
21 CFR Part 11 indirectly describes PC or higher "computerized systems", which are capable of the described administration functions for ERES (audit trail, user management, etc.). These functions can be easily implemented and handled in these systems with a maintainable effort.
However, small devices, which will be defined in the following, are sometimes only equipped with microprocessors and firmware and are not capable of the administration functions mentioned above. Moreover, data is often transient in nature in these devices.
It is not within the scope of this standard to determine the applicability of a predicate rule or to determine whether data subject to the system in question is GxP-relevant; nor does this guide deal with risk evaluation of the devices since this can be performed only for the application the device is used for. However, for the consideration of validation needs it is supposed that the device would be used in a critical (direct impact) application.
The scope of this standard is to provide guidance for an adapted and efficient use of 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, one will define and divide small devices in device classes in addition to the GAMP® categories. 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
• measuring transducers
All of the above examples are inclusive parameters.
Devices with data handling and transmission in analogue fashion do not have to be viewed in regard to 21 CFR Part 11.
Medical devices are not within the scope of this standard because they are impacted by other rules (e.g. 21 CFR 820).
The Guidance for Industry: Part 11, issued 28 August 2003, and its narrower definition of electronic records are also a basis for the standard.
Document History
