Core Insights - Kneat.com, Inc. has signed a Master Services Agreement with a U.S.-based global pharmaceutical packaging and drug-delivery manufacturer, marking a significant partnership in the digital validation and quality process automation sector [1][2] Company Overview - Kneat Solutions specializes in providing digital validation and compliance solutions for highly regulated industries, with its platform Kneat Gx recognized for its efficiency and user-friendly design [6] - The company is fully ISO 9001 and ISO 27001 certified, and its platform is compliant with 21 CFR Part 11/Annex 11, ensuring high standards of regulatory compliance [6] Customer and Market Impact - The new customer operates over 45 manufacturing facilities globally, employing more than 13,000 people across various regions, including the U.S., Europe, Asia, and South America [2] - The initial deployment of Kneat Gx will focus on Commissioning, Qualification, and Validation (CQV) at the customer's lead site, with plans for expansion to all GMP-regulated sites [2] Product Features and Benefits - Kneat's platform is noted for its robust data integrity capabilities, ensuring compliance actions and documented outcomes are fully attributable, traceable, and audit-ready [3] - The platform is designed to support the highest standards of data integrity and compliance, which is increasingly important as life sciences companies modernize their quality systems [4] - Kneat Gx has been shown to reduce man-hours associated with validation documentation by up to 50% and accelerate review and approval cycles by up to 50% [6]
Global Pharmaceutical Packaging Manufacturer Selects Kneat
Globenewswire·2026-02-19 22:03