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Un fabricant n'a pas validé des logiciels utilisés dans la production ou le contrôle de ses dispositifs médicaux : 2.    Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). a.    Your firm uses “(b)(4)” and “(b)(4)” to take (b)(4) of patients’ teeth and determine the desired movement pattern to generate your dental aligners. Your firm has not validated this software, you use as part of your production activities, for its intended use. b.    Your firm uses “(b)(4)” and “(b)(4)” to convert (b)(4) of patients’ impressions to file types compatible with the (b)(4) used to manufacture the molds for your dental aligners. You have not validated these software programs for their intended use . Plus d'information ici .

Ce fabricant indien a fait l'objet d'observations sur la "data integrity" dans une récente mise en demeure: 2.  Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. a.   Your firm failed to adequately control the use of computerized systems in the quality control laboratory. Our inspection team found that the laboratory manager had the ability to delete data from the Karl Fischer Tiamo software . During our limited review of your Karl Fischer data, we found that one file had been deleted. However, because the audit trail function for the Karl Fischer Tiamo software was not activated , and because eight different analysts share a single username and password , you were unable to demonstrate who performed each operation on this instrument system. You do not have a record of the acquisition of all data, nor do you have records of changes to or modifications of such data. b.   The inspection al...