mercredi 6 janvier 2016

Défaut de validation pour ce fabricant de dispositifs médicaux

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.

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"Data Integrity issues" pour ce fabricant indien

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 also found that a file containing the moisture content results for (b)(4) API batch (b)(4) had been deleted. This deletion was not identified and reviewed as part of your batch release decision. In your response, you indicated that the batch was within specifications according to raw data retrieved from the laboratory notebook. However, your response failed to address the deleted electronic record. You also did not indicate whether this deletion was an isolated incident or if other QC laboratory instruments and systems are configured to permit deletion of data...
3.  Your firm failed to ensure that all quality-related activities are recorded at the time they are performed.

Our inspection found that your firm’s employees use “rough or unofficial notebooks” to document various CGMP activities. During their walk-through, our investigators found “unofficial” notebooks in the engineering office at your Zyfine (b)(4) plant, in the quality assurance office at your Zyfine (b)(4) plant, and in the scrap yard shared by (b)(4) plants.

a.    For example, an “unofficial” notebook found in the engineering office stated, “Pseudomonas present in (b)(4) water system” on November 26, 2014 and “(b)(4) water system (Activity) investigation” on November 25, 2014. Your firm was unable to provide the investigators with any documentation regarding Pseudomonas sp. found in your water system and the related investigation.

b.    Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records. For example, page 22 included a comment on batch (b)(4) “not mentioned any deviations of lower yield.” Our review of the batch record (b)(4) found that the yield reported was (b)(4)% (range: (b)(4)%), but the batch record did not indicate a deviation.
c.    On their December 1, 2014 walk-through of the Zyfine (b)(4) plant, our investigators reviewed AHU/HVAC filter cleaning records. Duplicate records were in the engineering office. One of your firm’s representatives stated that the records were rewritten for clarity. Our review of the original and rewritten records found discrepancies in cleaning dates and cleaning personnel.
Plus d'information ici.