Kneat.com Inc. (FOBK)

Overview

Kneat.com, inc., and its subsidiaries operate in the provision of sophisticated software solutions aimed at data and document management within highly regulated environments. The company has a geographical footprint that spans across North America, Europe, and the Asia Pacific regions. Kneat.com’s flagship Kneat Gx platform is designed to cater to the stringent needs of the biotechnology, pharmaceutical, and medical device manufacturing industries, focusing on validation lifecycle management and testing. Headquarters based in Limerick, Ireland, the company leverages its global presence to serve a wide range of customers, ensuring compliance and efficiency in some of the most critically regulated sectors.

Products and Services

• Kneat Gx platform

A configurable off-the-shelf application that streamlines validation lifecycle management and testing processes. It addresses the complex regulatory requirements of the biotechnology, pharmaceutical, and medical device manufacturing industries, providing robust document management and validation functionalities.

• Document Management

Helps organizations control, manage, and track documents in a secure and efficient manner. This is crucial for maintaining compliance with industry regulations and standards.

• Analytical Instrument Validation

Ensures that analytical instruments perform as expected and within specified parameters, critical for the accuracy of test results in the pharmaceutical and biotechnological sectors.

• Method Validation

Facilitates the process of proving that an analytical method is acceptable for its intended use, ensuring reliability and compliance in the development and production processes.

• Commissioning and Qualification

Supports the systematic and documented process of ensuring that systems and sub-systems perform in accordance with their intended use and design specifications.

• Drawing Management

Provides solutions for the management and control of engineering drawings, essential for maintaining the integrity of manufacturing operational processes.

• Utility and Facility Validation

Involves the verification of utilities and facilities to ensure they meet the required specifications and regulatory standards for manufacturing operations.

• Cold Chain Validation

Ensures that products sensitive to temperature are stored, handled, and transported within specified temperature ranges throughout the supply chain.

• Electronic Logbook Management

Offers a digital solution for recording and storing log entries, replacing traditional paper logbooks and enhancing data integrity and traceability.

• Process Validation

Concerned with establishing documented evidence that a process consistently produces a result or product meeting its predetermined specifications and quality attributes.

• Computer System Validation

Provides assurance that computer systems perform their functions within the specified guidelines and meet the regulatory requirements specific to the industry.

• Cleaning Validation

Verifies the effectiveness of cleaning procedures for equipment to prevent contamination and ensure product quality and safety.

In addition to the comprehensive software solutions, kneat.com, inc. also extends professional services encompassing consulting, training, process mapping, project management, and other support services to ensure successful implementations and maximized utility of their platform.