Absence de validation sur un logiciel de sérialisation...

Pour ce fabricant qui n'avait pas validé le logiciel qui générait les numéros de série de ses dispositifs médicaux, la FDA pointe un écart dans cette récente mise en demeure :

2.    Failure to validate computer software for its intended use according to an established protocol when computer or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has been using the (b)(4) software program to generate a unique serial number for each product since 2011. The serial number is used on the inner and outer packing of the finished device for tracking purpose. However, during the inspection, your firm stated to the FDA investigator that it has not validated the (b)(4) software program and it has no established protocol for doing so.
 We reviewed your firm’s response and conclude that it is not adequate. The response included Serialization Procedure PRO-SP-0804, revision A. This procedure describes how your firm generates a unique serial number and uses it to track products throughout its shipment process. However, the procedure does not describe how your firm will validate the computer software for its intended use.