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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard

Section: 5.5

Question:  Are electronic records sufficient for instrument maintenance?  If not, can the electronic records be printed and indexed periodically (perhaps monthly) to satisfy hard copy requirements?  We can currently record all maintenance in our LIMS system.

TNI Response:  There is nothing stated in 5.5.5 that states that records must be hard copy. If the records are maintained in a secure manner (presumably the LIMS contains audit trails and password protection), all of the items required in 5.5.5 are maintained, and any other requirements for records and records maintenance are met, this should be allowed.


Question:  Does the requirement in 5.5.8 to indicate the status of calibration apply to devices such as a TCLP tumbler?  Although we check the rotational rate monthly, there does not seem to be any adjustment on this device.  Some support equipment has no "calibration" and would seem to be exempt from this regulation. 

TNI Response:  The cited section is preceded by "Whenever practicable". If a piece of support equipment does not require a calibration, it cannot require a notification of calibration status. It may, however, have an indication of the verification of its effectiveness (e.g., such as a date when the number of revolutions per minute on a TCLP tumbler was verified).