Global Medical Device Manufacturer Selects Kneat to Digitize Computer System Validation
December 17 2024 - 4:07PM
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 RelationsP: + 1 902-450-2660 E:
investors@kneat.com
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