Carence de validation pour ce fabricant de dispositifs médicaux...
Ce fabricant de dispositifs médicaux s'est fait épingler pour défaut de validation sur plusieurs systèmes impliqués dans la fabrication ou le contrôle des dispositifs médicaux :
2. Software used as part of production
and the quality system has not been validated for its intended use
according to an established protocol, as required by 21 CFR
820.70(i). Specifically, software validation was not conducted for the
following pieces of equipment:
Automated Production Equipment
|
Quality Inspection Equipment
|
(b)(4)
|
(b)(4)
|
(b)(4)
|
(b)(4)
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(b)(4)
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The
corrective actions outlined in your firm’s responses appear adequate
and will be verified during a during a follow-up FDA inspection.
Rappelons ce que précise le texte 820.70(i) sur ce sujet :
...When computers or automated data processing
systems are used as part of production or the quality system, the
manufacturer shall validate computer software for its intended use
according to an established protocol. All software changes shall be
validated before approval and issuance. These validation activities and
results shall be documented.
Plus d'information ici.
