Une nouvelle Warning letter met en évidence des insuffisances dans l'évaluation des fournisseurs et la validation informatique
Dans cette récente mise en demeure adressée à une entreprise allemande, la FDA pointe des manquements sur ces sujets déjà abordés.
3. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR 820.50(a)(1). For example, there was no documented evidence of suppliers, contractors, and consultants being evaluated and selected based on their ability to meet specified requirements.
7. Failure to validate, for its intended use, computer software used as part of production or the quality system according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses an (b)(4) software system to (b)(4). This software system has not been validated by the firm.
3. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR 820.50(a)(1). For example, there was no documented evidence of suppliers, contractors, and consultants being evaluated and selected based on their ability to meet specified requirements.
7. Failure to validate, for its intended use, computer software used as part of production or the quality system according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses an (b)(4) software system to (b)(4). This software system has not been validated by the firm.
