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.
TNI FINAL RESPONSE:
(Quality Systems Expert Committee/NELAP Board, 10-11-09)
There is nothing stated in 220.127.116.11 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 18.104.22.168 are maintained, and any other requirements for records and records maintenance are met, this should be allowed.