Global Medical Device Manufacturer Selects Kneat to Digitize Computer System Validation
Global Medical Device Manufacturer Selects Kneat to Digitize Computer System Validation
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.
愛爾蘭利默里克,2024年12月17日(環球新聞) -- kneat.com公司(TSX:KSI)(OTCQC:KSIOF),數字化和自動化驗證與質量流程的領導者,欣然宣佈一家醫療設備和醫療療法制造商("該公司")已與Kneat簽署了一項爲期三年的主服務協議,以優化其計算機系統驗證流程。
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).
這家總部位於美國的公司在美國、拉丁美洲和歐洲進行生產,銷售業務遍及100多個國家,提供一系列創新的醫療解決方案,旨在協助醫療提供者提供有效的患者治療。作爲一家擁有超過15,000名員工的更大生命科學組織的一個部門,該公司將在初期使用Kneat Gx進行計算機系統驗證(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."
"我們歡迎這家領導者加入我們不斷增長的醫療設備投資組合,"Kneat首席執行官Eddie Ryan說。"這一勝利彰顯了Kneat Gx在醫療設備板塊滿足計算機系統驗證業務需求的能力。"
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.
該公司希望藉助全球分散的驗證團隊在遠程工作的情況下,從人工混合紙質流程轉變爲優化的數字化流程,以改善多種IT系統驗證的協作、可視性、速度和協調性。Kneat在降低驗證成本的同時提供更高的合規標準,良好的表現使Kneat能夠擴展到該組織中的其他驗證使用案例。
About Kneat
關於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 40% reduction in documentation cycle times, up to 20% faster speed to market, and a higher compliance standard.
Kneat Solutions爲高度監管行業的領先公司提供無與倫比的驗證和合規效率,通過其數字驗證平台Kneat Gx。我們在客戶滿意度方面位居行業領先,擁有無可挑剔的實施記錄,得益於我們用戶友好的設計、專業的支持和按需的培訓Academy。Kneat Gx是行業領先的數字驗證平台,使高度監管的公司能夠從頭到尾管理任何驗證學科。Kneat Gx完全符合ISO 9001和ISO 27001認證,經過全面驗證,並符合21 CFR第11部分/附錄11的要求。多項獨立客戶研究表明,文檔週期時間減少高達40%,上市速度提高高達20%,並且合規標準更高。
Cautionary and Forward-Looking Statements
警示性及前瞻性聲明
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.
除文中包含的歷史事實陳述外,某些信息構成適用的加拿大證券法下的「前瞻性信息」。此類前瞻性信息包括但不限於Kneat與客戶之間的關係、Kneat的業務發展活動、Kneat軟件在客戶驗證流程中的使用和實施時間表、客戶在其組織內擴大使用Kneat軟件的能力和意圖,以及Kneat平台在監管審計和檢查中的合規性。雖然此類前瞻性陳述由Kneat以良好的信念表述,並被Kneat認爲具有合理依據,但它們仍然面臨重要的風險和不確定性。由於這些風險和不確定性,前瞻性陳述中預測的事件可能與實際結果或事件有實質性差異。這些前瞻性陳述並不保證未來的表現,因爲它們涉及風險和不確定性。
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.
Kneat不會承擔任何義務公開修訂任何前瞻性聲明,除非適用的證券法律要求。投資者不應假設對以前發佈的前瞻性聲明缺乏更新構成對該聲明的再確認。繼續依賴前瞻性聲明的風險由投資者自行承擔。
For further information:
更多信息:
Katie Keita, Kneat Investor Relations
P: + 1 902-450-2660
E: investors@kneat.com
Katie Keita,Kneat投資者關係
電話:+ 1 902-450-2660
郵箱:investors@kneat.com
譯文內容由第三人軟體翻譯。