Absence de validation sur un système de SAV
La société FISIOLINE (dispositifs médicaux) a été notifiée d'un écart par la FDA pour la non validation de son logiciel de SAV :
4. 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). For example, the software developed by your firm to record, evaluate, investigate, correct and repair incoming technical assistance calls, complaints, and service records was implemented in the first part of October 2012, and has not been validated. No validation documentation was available for an established protocol, any testing data, or a finished report for the validation of this system. Mr. Lucca Ferrua, the Assistant Manager, indicated that your firm had not validated the software system.
Ainsi que des lacunes sur la qualification de conception :
Plus d'information ici.
4. 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). For example, the software developed by your firm to record, evaluate, investigate, correct and repair incoming technical assistance calls, complaints, and service records was implemented in the first part of October 2012, and has not been validated. No validation documentation was available for an established protocol, any testing data, or a finished report for the validation of this system. Mr. Lucca Ferrua, the Assistant Manager, indicated that your firm had not validated the software system.
Ainsi que des lacunes sur la qualification de conception :
5. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, the design validation procedures outlined in “PP1 Design and Development” do not include:
a) requirements which ensure that protocols with acceptance criteria are established prior to the performance of validation activities; and
b) requirements which ensure that the results of design validation, including the identification of the design, the methods, and the measuring equipment used, are documented and filed in the design history file.
Software validation documentation for a new user interface on an existing laser model did not document the above information.
Plus d'information ici.
