Global Medical Device Manufacturer Selects Kneat to Digitize Computer System Validation
Kneat (TSX: KSI, OTCQC: KSIOF) has secured a three-year Master Services Agreement with a global medical device manufacturer to digitize their computer system validation (CSV) processes. The client, which operates in over 100 countries with manufacturing facilities in the United States, Latin America, and Europe, is part of a larger life sciences organization employing more than 15,000 people worldwide.
The agreement aims to transform the client's manual hybrid paper process into a streamlined digital solution, enhancing collaboration, visibility, speed, and harmonization for validating multiple IT systems. Kneat Gx was selected for its demonstrated ability to reduce validation costs while maintaining high compliance standards, with potential for expansion to additional validation use cases within the organization.
Kneat (TSX: KSI, OTCQC: KSIOF) ha siglato un contratto di Master Services della durata di tre anni con un produttore globale di dispositivi medici per digitalizzare i loro processi di validazione dei sistemi informatici (CSV). Il cliente, che opera in oltre 100 paesi con strutture di produzione negli Stati Uniti, in America Latina e in Europa, fa parte di una più grande organizzazione delle scienze della vita che impiega oltre 15.000 persone in tutto il mondo.
L'accordo mira a trasformare il processo ibrido manuale su carta del cliente in una soluzione digitale semplificata, migliorando la collaborazione, la visibilità, la velocità e l'armonia nella validazione di più sistemi IT. Kneat Gx è stato scelto per la sua comprovata capacità di ridurre i costi di validazione mantenendo elevati standard di conformità, con potenzialità di espansione a ulteriori casi di utilizzo della validazione all'interno dell'organizzazione.
Kneat (TSX: KSI, OTCQC: KSIOF) ha conseguido un contrato de Master Services de tres años con un fabricante global de dispositivos médicos para digitalizar sus procesos de validación de sistemas informáticos (CSV). El cliente, que opera en más de 100 países con instalaciones de fabricación en Estados Unidos, América Latina y Europa, forma parte de una organización más grande de ciencias de la vida que emplea a más de 15,000 personas en todo el mundo.
El acuerdo tiene como objetivo transformar el proceso híbrido manual en papel del cliente en una solución digital eficiente, mejorando la colaboración, visibilidad, velocidad y armonización para validar múltiples sistemas de TI. Kneat Gx fue seleccionado por su capacidad demostrada de reducir los costos de validación mientras mantiene altos estándares de cumplimiento, con potencial de expansión a más casos de uso de validación dentro de la organización.
Kneat (TSX: KSI, OTCQC: KSIOF)는 전 세계 의료기기 제조 업체와 3년간의 마스터 서비스 계약을 체결하여 컴퓨터 시스템 검증(CSV) 프로세스를 디지털화합니다. 이 고객은 미국, 라틴 아메리카 및 유럽에 제조 시설을 두고 100개국 이상에서 운영되며, 15,000명이 넘는 인력을 고용하는 대규모 생명 과학 조직의 일부입니다.
이번 계약의 목표는 고객의 수동 하이브리드 종이 프로세스를 간소화된 디지털 솔루션으로 전환하여 여러 IT 시스템 검증 시의 협업, 가시성, 속도 및 조화를 향상시키는 것입니다. Kneat Gx는 높은 준수 기준을 유지하면서 검증 비용을 줄이는 입증된 능력 덕분에 선택되었으며, 조직 내의 추가 검증 사용 사례로 확장이 가능성이 있습니다.
Kneat (TSX: KSI, OTCQC: KSIOF) a conclu un contrat de services principal de trois ans avec un fabricant mondial de dispositifs médicaux afin de numériser ses processus de validation des systèmes informatiques (CSV). Le client, qui opère dans plus de 100 pays avec des installations de fabrication aux États-Unis, en Amérique latine et en Europe, fait partie d'une grande organisation de sciences de la vie employant plus de 15 000 personnes dans le monde entier.
L'accord vise à transformer le processus hybride manuel sur papier du client en une solution numérique rationalisée, améliorant la collaboration, la visibilité, la rapidité et l'harmonisation pour la validation de plusieurs systèmes informatiques. Kneat Gx a été sélectionné pour sa capacité démontrée à réduire les coûts de validation tout en maintenant des normes de conformité élevées, avec un potentiel d'expansion à d'autres cas d'utilisation de validation au sein de l'organisation.
Kneat (TSX: KSI, OTCQC: KSIOF) hat einen dreijährigen Master Services Vertrag mit einem globalen Hersteller von medizinischen Geräten abgeschlossen, um deren Validierungsprozesse für Computersysteme (CSV) zu digitalisieren. Der Kunde, der in über 100 Ländern mit Produktionsstätten in den Vereinigten Staaten, Lateinamerika und Europa tätig ist, gehört zu einer größeren Organisation im Bereich Lebenswissenschaften, die weltweit mehr als 15.000 Mitarbeiter beschäftigt.
Das Ziel des Vertrags ist es, den manuellen Hybridpapierprozess des Kunden in eine optimierte digitale Lösung umzuwandeln, die die Zusammenarbeit, Sichtbarkeit, Geschwindigkeit und Harmonisierung bei der Validierung mehrerer IT-Systeme verbessert. Kneat Gx wurde aufgrund seiner nachgewiesenen Fähigkeit ausgewählt, Validierungskosten zu senken und zugleich hohe Compliance-Standards aufrechtzuerhalten, mit Potenzial für die Erweiterung auf zusätzliche Validierungsanwendungsfälle innerhalb der Organisation.
- Secured new three-year Master Services Agreement with global medical device manufacturer
- Client has operations in 100+ countries, indicating significant expansion potential
- Solution demonstrates cost reduction capabilities while maintaining compliance standards
- Potential for expanding services to additional validation use cases within the client organization
- None.
LIMERICK, Ireland, Dec. 17, 2024 (GLOBE NEWSWIRE) -- kneat.com, inc. (TSX: KSI) (OTCQC: KSIOF), a leader in digitizing and automating validation and quality processes, is pleased to announce that a manufacturer of medical devices and healthcare therapies (“the Company”) has signed a three-year Master Services Agreement with Kneat to streamline its computer system validation process.
This US-headquartered Company manufactures in the United States, Latin America and Europe with sales operations in more than 100 countries, providing a comprehensive range of innovative medical solutions designed to assist healthcare providers in delivering effective patient treatments. As a division of a larger life sciences organization with more than 15,000 employees located across Europe, Asia, Africa, and the Americas, the Company will use Kneat Gx initially for computer system validation (CSV).
“We welcome this leader to our growing medical devices portfolio,” said Eddie Ryan, Chief Executive Officer of Kneat. “This win highlights Kneat Gx’s ability to meet the business needs for computer systems validation within the medical devices sector.”
With a globally dispersed validation team working remotely, the Company was looking to move from a manual hybrid paper process to a streamlined digital one for better collaboration, visibility, speed, and harmonization for the validation of multiple IT systems. Kneat’s demonstrated ability to slash validation costs while delivering a higher compliance standard positions Kneat well for expansion to additional validation use cases within the organization.
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 up to
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
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