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Standard Interpretation

Standard: 2003 NELAC
Link to relevant standard


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.


(Quality Systems Expert Committee/NELAP Board, 10-11-09)

There is nothing stated in 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 are maintained, and any other requirements for records and records maintenance are met, this should be allowed.