{"id":12380,"date":"2022-02-08T19:56:11","date_gmt":"2022-02-08T19:56:11","guid":{"rendered":"https:\/\/www.augmentir.com\/?p=12380"},"modified":"2023-03-08T20:25:20","modified_gmt":"2023-03-08T20:25:20","slug":"another-successful-fda-audit-in-the-books","status":"publish","type":"post","link":"https:\/\/www.augmentir.com\/de\/blog\/another-successful-fda-audit-in-the-books","title":{"rendered":"Ein weiteres erfolgreiches FDA-Audit in den B\u00fcchern"},"content":{"rendered":"

K\u00fcrzlich hat Augmentir ein strenges Lieferantenqualifizierungsaudit als Teil der Good Manufacturing Practice (GMP) eines Tier-1-Pharmaherstellungsunternehmens abgeschlossen, und wir freuen uns, Ihnen mitteilen zu k\u00f6nnen, dass unser Produkt das Audit erfolgreich bestanden hat.<\/span><\/p>\n

Entsprechend der <\/span>Internationale Gesellschaft f\u00fcr Pharmazeutische Technik<\/span><\/a>, GMP-Vorschriften verlangen, dass pharmazeutische Hersteller die Herstellungsvorg\u00e4nge angemessen kontrollieren und einen Qualit\u00e4tsansatz f\u00fcr die Herstellung etablieren, der es Unternehmen erm\u00f6glicht, F\u00e4lle von Kontamination, Verwechslungen und Fehlern zu minimieren oder zu eliminieren. Die Verwendung der Connected-Worker-Software von Augmentir ist eine entscheidende Komponente f\u00fcr die Fertigung innerhalb der Pharmazie und Life Sciences<\/a> Umwelt, da es hilft, Fehler zu reduzieren und die Einhaltung dieser Vorschriften sicherstellt.<\/span><\/p>\n

Dieses Qualifizierungsaudit, das vom leitenden Auditor unseres Kunden und dem leitenden QA-Validierungsspezialisten durchgef\u00fchrt wurde, bewertete die Angemessenheit und Wirksamkeit f\u00fcr die Einhaltung und Einhaltung gesetzlicher Anforderungen. Die Qualit\u00e4t und Effektivit\u00e4t sowie die Einhaltung des Qualit\u00e4tsmanagementsystems (QMS), der Richtlinien und Verfahren des Standorts wurden ebenfalls bewertet, und schlie\u00dflich wurde Augmentir als Anbieter von Unternehmens-IT-Systemen\/Infrastrukturen zugelassen.\u00a0<\/span><\/p>\n

Audits wie diese sind f\u00fcr jedes Unternehmen eine Herausforderung und k\u00f6nnen f\u00fcr kleine Unternehmen wie Augmentir noch gr\u00f6\u00dfere Herausforderungen darstellen. Es ist jedoch \u00e4u\u00dferst wichtig, da GMP-Vorschriften einen Qualit\u00e4tsansatz f\u00fcr die Herstellung gew\u00e4hrleisten und Unternehmen dabei helfen, Fehler, Irrt\u00fcmer und F\u00e4lle von Kontamination zu minimieren.\u00a0\u00a0<\/span><\/p>\n

Bei Augmentir haben wir bisher mehrere Audits erfolgreich abgeschlossen und freuen uns, dieses pharmazeutische GMP-Audit zu dieser Liste hinzuzuf\u00fcgen, w\u00e4hrend wir die Schritte unserer alten Produkte fortsetzen. Diese Audits sind f\u00fcr unser Team nicht neu, und dieser j\u00fcngste Meilenstein ist eine Fortsetzung von <\/span>unsere Geschichte bei der Einf\u00fchrung innovativer, hochwertiger Software in den Fertigungssektor<\/span><\/a>, das in der Geschichte der Softwareprodukte, an denen unser Team beteiligt war, mehr als sch\u00e4tzungsweise 100.000 gepr\u00fcfte Prozesse durchgef\u00fchrt hat.<\/span><\/p>\n

Zu Beginn des Jahres 2022 ist dieser Abschluss des pharmazeutischen GMP-Audits ein Beweis f\u00fcr Augmentir, unser Team und unser Engagement f\u00fcr die Aufrechterhaltung der h\u00f6chsten globalen Qualit\u00e4tsstandards und best\u00e4tigt unseren Erfolg in der pharmazeutischen Industrie.\u00a0<\/span><\/p>\n

Auf unser n\u00e4chstes erfolgreiches Audit!<\/span><\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

K\u00fcrzlich hat Augmentir ein strenges Qualifizierungsaudit als Teil der Good Manufacturing Practice (GMP) eines Tier-1-Pharmaherstellungsunternehmens abgeschlossen, und wir freuen uns, Ihnen mitteilen zu k\u00f6nnen, dass unser Produkt das Audit erfolgreich bestanden hat.<\/p>","protected":false},"author":1,"featured_media":12381,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"_lmt_disableupdate":"no","_lmt_disable":"","footnotes":""},"categories":[4],"tags":[86,47,85,84,87,83,88],"class_list":["post-12380","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-audit","tag-connected-worker","tag-fda","tag-gmp","tag-pharmaceutical-manufacturing","tag-quality","tag-validated"],"yoast_head":"\nAnother Successful FDA Audit in the Books - Augmentir<\/title>\n<meta name=\"description\" content=\"Recently, Augmentir completed a rigorous quality audit as part of a Tier 1 Pharmaceutical Manufacturing company\u2019s Good Manufacturing Practice (GMP), and we are pleased to announce that our product successfully passed the audit.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.augmentir.com\/de\/blog\/another-successful-fda-audit-in-the-books\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Another Successful FDA Audit in the Books - 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