Tag: Medical device

CAI’s Kneat Gx System Qualified & Released for Use

Posted on by

CAI

INDIANAPOLIS — CAI, a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and industrial process manufacturing industries, today confirmed its status as an official Kneat Platform Partner with the launch of its own validated Kneat Gx software instance following the initial development of a strategic partnership with Kneat Solutions in early 2022.

The Kneat Gx instance, a 21 CFR Part 11 and Annex 11 electronic records and signatures compliant SaaS validation solution, enables CAI to host work product on behalf of its clients, including reviews, approvals, and execution of protocols.

The CAI instance of Kneat Gx will provide a mechanism for Knowledge Management that is married directly to work product, by enabling tools and templates to be stored and managed in the same platform and format, where they can and should be used.

“Our Kneat Gx environment gives us the ability to serve our clients more efficiently, using industry best in class standardized off-the-shelf content while removing the geographic obstacles to collaboration within our global network of industry professionals,” states Mike Martin, CEO of CAI. He continues, “I am excited for what the future holds!”

“CAI continues to demonstrate their commitment to enhancing their client experience and results through the adoption of digital validation and through their partnership with Kneat,” commented Rick Mineo, Director of Strategic Partnerships at Kneat. “We are very pleased to partner with CAI, and we look forward to continuing to scale our solutions”

https://cagents.com/


About CAI:
Since CAI’s founding in 1996, we have delivered nearly a billion dollars in services for hundreds of clients across thousands of projects globally. With offices in the US, Canada, Australia, Netherlands, Korea, Switzerland, India, Ireland, Italy, China, Singapore, United Kingdom, and Malaysia, we have built an international team of over 850 professionals providing local support from a global company. Our engineering, technical, and consulting services deliver mission critical facilities with a high level of performance and reliability. When operational readiness is critical, CAI delivers to a higher standard.

About Kneat:
Kneat, a Canadian company with operational headquarters in Limerick, Ireland, develops and markets the next generation Kneat Gx SaaS platform. Multiple business work processes can be configured on the platform from equipment to computer system validation, through to quality document management. Kneat’s software allows users to author, review, approve, execute testing online, manage any exceptions, and post approve final deliverables in a controlled FDA 21 CFR Part 11/ Eudralex Annex 11 compliant platform. Macro and micro report dashboards enable powerful oversight into all systems, projects and processes globally. Customer case studies are reporting productivity improvements in excess of 100% and a higher data integrity and compliance standard. For more information visit www.kneat.com

Media Contact:
David Shenberger
+13177219847
[email protected]

TOMZ Corporation to Open Second Manufacturing Facility in Knightstown

Posted on by

TOMZ Corporation

KNIGHTSTOWN – TOMZ Corporation, a manufacturer of implantable medical devices based in Connecticut, will celebrate the opening of its second manufacturing facility in Knightstown, Indiana on Friday, August 13th. The state-of-the-art 60,000 sq. ft. facility is located near Warsaw, Indiana, also known as the “Orthopedic Capitol of the World,” allowing TOMZ to join many of its peers in orthopedics, while the accompanying 18-acre parcel allows for tremendous growth opportunity.

TOMZ Corporation’s experience in the field of medical device manufacturing spans more than three decades, with millions of medical devices in use today. TOMZ has consolidated manufacturing processes at its 150,000 sq. ft. headquarters in Berlin, Connecticut to offer shorter lead times, faster delivery, and excellent quality control. After 8 expansions of the Berlin facility, with the most recent completed in the summer of 2020, the Indiana facility will reinforce and greatly increase capacity.

With this second facility, TOMZ Corporation is looking forward to bringing a wider product range, increased volume, and additional capabilities as an instrumental partner of top medical OEMs in the medical device space.

Needless to say, there are many employment opportunities available. For mor information on TOMZ please visit their website: www.tomz.com

TOMZ Corporation is a top-tier manufacturer of implantable medical devices for the world’s leading medical OEMs, headquartered in Berlin, Connecticut. The core of their business is medical device implants, their assemblies, and accompanying surgical instruments.