Global Medical Devices Manufacturer Selects Kneat to Digitize Validation
A global medical devices manufacturer has signed a three-year Master Services Agreement with Kneat to digitize its validation processes. The client, headquartered in Germany, employs over 11,000 people and operates 30+ production sites across 15 countries in Europe, Asia and the Americas. The company provides solutions to pharma, biotech and cosmetic industries, including pharmaceutical packaging, drug delivery systems, diagnostic devices, and digital healthcare solutions. They plan to implement the Kneat Gx platform for Commissioning, Qualification and Validation (CQV) processes.
Un produttore globale di dispositivi medici ha firmato un contratto di servizi Master triennale con Kneat per digitalizzare i propri processi di convalida. Il cliente, con sede in Germania, impiega oltre 11.000 persone e opera in oltre 30 siti produttivi in 15 paesi tra Europa, Asia e Americhe. L'azienda offre soluzioni ai settori farmaceutico, biotech e cosmetico, comprese imballaggi farmaceutici, sistemi di somministrazione di farmaci, dispositivi diagnostici e soluzioni sanitarie digitali. Hanno in programma di implementare la piattaforma Kneat Gx per i processi di Commissioning, Qualification e Validation (CQV).
Un fabricante global de dispositivos médicos ha firmado un contrato de servicios maestro de tres años con Kneat para digitalizar sus procesos de validación. El cliente, que tiene su sede en Alemania, emplea a más de 11,000 personas y opera en más de 30 sitios de producción en 15 países en Europa, Asia y las Américas. La empresa proporciona soluciones a las industrias farmacéutica, biotecnológica y cosmética, incluyendo empaques farmacéuticos, sistemas de entrega de medicamentos, dispositivos de diagnóstico y soluciones de salud digital. Tienen planes de implementar la plataforma Kneat Gx para los procesos de Comisionado, Calificación y Validación (CQV).
글로벌 의료 기기 제조업체가 Kneat와 3년 마스터 서비스 계약을 체결하여 검증 프로세스를 디지털화합니다. 독일에 본사를 둔 이 고객은 11,000명 이상을 고용하고 있으며 유럽, 아시아 및 아메리카에서 30개 이상의 생산 시설를 운영하고 있습니다. 이 회사는 제약, 생명공학 및 화장품 산업에 솔루션을 제공하며, 제약 포장, 약물 전달 시스템, 진단 장치 및 디지털 건강 솔루션을 포함합니다. 그들은 알림, 자격 및 검증(CQV) 프로세스를 위해 Kneat Gx 플랫폼을 구현할 계획입니다.
Un fabricant mondial de dispositifs médicaux a signé un contrat de services principal de trois ans avec Kneat pour numériser ses processus de validation. Le client, dont le siège est en Allemagne, emploie plus de 11 000 personnes et opère dans plus de 30 sites de production répartis dans 15 pays en Europe, en Asie et en Amérique. L'entreprise fournit des solutions aux secteurs pharmaceutique, biotechnologique et cosmétique, notamment des emballages pharmaceutiques, des systèmes d'administration de médicaments, des dispositifs de diagnostic et des solutions de santé numériques. Ils prévoient d'implémenter la plateforme Kneat Gx pour les processus de mise en service, de qualification et de validation (CQV).
Ein globaler Hersteller von medizinischen Geräten hat einen Dreijahresvertrag über Master-Services mit Kneat unterzeichnet, um seine Validierungsprozesse zu digitalisieren. Der Kunde mit Hauptsitz in Deutschland beschäftigt über 11.000 Mitarbeiter und betreibt 30+ Produktionsstandorte in 15 Ländern in Europa, Asien und Amerika. Das Unternehmen bietet Lösungen für die Pharma-, Biotech- und Kosmetikindustrie an, einschließlich pharmazeutischer Verpackungen, Arzneimittelabgabesysteme, Diagnosetechnologien und digitalen Gesundheitslösungen. Sie planen, die Kneat Gx-Plattform für die Prozesse der Inbetriebnahme, Qualifikation und Validierung (CQV) zu implementieren.
- Secured three-year Master Services Agreement with a major global medical devices manufacturer
- Client has significant global presence with 30+ production sites across 15 countries
- Expansion into medical devices sector strengthens market position
- None.
LIMERICK, Ireland, Oct. 31, 2024 (GLOBE NEWSWIRE) -- kneat.com, inc. (TSX: KSI) (OTC: KSIOF), a leader in digitizing and automating validation and quality processes, is pleased to announce that a global and diverse medical devices manufacturer has signed a three-year Master Services Agreement with Kneat to digitize its validation processes.
The Company provides solutions to the pharma, biotech and cosmetic industries, including pharmaceutical primary packaging, drug delivery systems, diagnostic and medical devices, and digital healthcare solutions. Headquartered in Germany, the Company employs more than 11,000 people and operates over 30 production sites in 15 countries across Europe, Asia and the Americas. The company plans to use the Kneat Gx platform initially for Commissioning, Qualification and Validation (CQV).
“Kneat is proud to support this company which has a long history of uncompromising quality,” said Eddie Ryan, Chief Executive Officer of Kneat. “This win demonstrates the value that Kneat can deliver for global companies operating in the Life Sciences supply chain.”
About Kneat
Kneat Solutions provides leading companies in highly regulated industries with unparalleled efficiency in validation and compliance through its digital validation platform Kneat Gx. We lead the industry in customer satisfaction with an unblemished record for implementation, powered by our user-friendly design, expert support, and on-demand training academy. Kneat Gx is an industry-leading digital validation platform that enables highly regulated companies to manage any validation discipline from end-to-end. Kneat Gx is fully ISO 9001 and ISO 27001 certified, fully validated, and 21 CFR Part 11/Annex 11 compliant. Multiple independent customer studies show a
Cautionary and Forward-Looking Statements
Except for the statements of historical fact contained herein, certain information presented constitutes “forward-looking information” within the meaning of applicable Canadian securities laws. Such forward-looking information includes, but is not limited to, the relationship between Kneat and the customer, Kneat’s business development activities, the use and implementation timelines of Kneat’s software within the customer’s validation processes, the ability and intent of the customer to scale the use of Kneat’s software within the customer’s organization and the compliance of Kneat’s platform under regulatory audit and inspection. While such forward-looking statements are expressed by Kneat, as stated in this release, in good faith and believed by Kneat to have a reasonable basis, they are subject to important risks and uncertainties. As a result of these risks and uncertainties, the events predicted in these forward-looking statements may differ materially from actual results or events. These forward-looking statements are not guarantees of future performance, given that they involve risks and uncertainties.
Kneat does not undertake any obligation to release publicly revisions to any forward-looking statement, except as may be required under applicable securities laws. Investors should not assume that any lack of update to a previously issued forward-looking statement constitutes a reaffirmation of that statement. Continued reliance on forward-looking statements is at an investor’s own risk.
For further information:
Katie Keita, Kneat Investor Relations
P: + 1 902-450-2660
E: investors@kneat.com
FAQ
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