Global Medical Device Manufacturer Selects Kneat to Digitize Computer System Validation

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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 40% reduction in documentation cycle times, up to 20% faster speed to market, and a higher compliance standard.

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

What is the duration of Kneat's (KSIOF) new Master Services Agreement with the medical device manufacturer?

The Master Services Agreement has a duration of three years.

What specific solution will the medical device manufacturer implement from Kneat (KSIOF)?

The manufacturer will implement Kneat Gx specifically for computer system validation (CSV).

How many countries does Kneat's (KSIOF) new medical device client operate in?

The client has sales operations in more than 100 countries globally.

What are the main benefits of Kneat's (KSIOF) solution for the medical device manufacturer?

The solution offers better collaboration, visibility, speed, and harmonization for validation of multiple IT systems, while reducing validation costs and maintaining high compliance standards.

Where are the manufacturing facilities located for Kneat's (KSIOF) new client?

The client's manufacturing facilities are located in the United States, Latin America, and Europe.