Des écarts dans la validation des SI pour ces fournisseurs de dispositifs médicaux...

Des mises en demeure récentes de la US FDA mettent en évidence des manquements dans la validation des systèmes informatisés pour des fabricants de dispositifs médicaux :

5.    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, as per CAPA report number AP_009/13 your firm implemented a(b)(4) to conduct quality control functions such as, but not limited to, verifying menstrual pad shape, size, and missing parts. However, your firm was unable to demonstrate that the (b)(4) was validated for its intended use.
 We reviewed your firm’s responses and conclude that they are not adequate. Your firm’s response indicated that your firm has initiated CAPA number AC016/13 to address the above deficiencies. As part of the CAPA, your firm has revised its Process Validation procedure, 8P-44, edition 00. Your firm’s revised procedure is deficient in that it does not reference the process that your firm follows in order to determine whether a process requires validation. Your firm’s response did not indicate whether your firm plans to conduct a retrospective review of existing (b)(4) for similar deficiencies. Your firm’s response indicated that personnel training was conducted; however, training documents were not submitted for review.

3.    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, during the inspection your firm confirmed that its software program(b)(4) version (b)(4) released on August 28, 2009, for documenting condom production control tests has not been validated for its intended uses. 

We reviewed your firm’s response and conclude that it is not adequate. The response indicated that your firm’s supplier has validated the (b)(4) software and validations will be documented by week 49/13. Your firm should clarify the intended uses of the software. If the software is responsible for calculating data, your firm should validate the software as required by 21 CFR 820.70(i). Your firm should provide evidence of implementation of its corrective actions. Specifically, your firm should provide a copy of its software validation procedures, a summary of the validation test results and personnel training records, if appropriate, for review. 

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