Kneat

Kneat is a software company that develops a digital validation platform purpose-built for the life sciences industry. The platform is designed to digitalize, manage, and streamline validation processes across biotechnology, pharmaceuticals, medical devices, and consumer health organisations. Kneat serves quality assurance and validation teams seeking to improve data integrity, reduce cycle times, and maintain continuous audit readiness — replacing paper-based and fragmented systems with a single, configurable solution.

Eight of the world's top ten life sciences companies use Kneat, and the majority of the top twenty life sciences companies have implemented the platform. Customers include Biogen, Merck Sharp & Dohme, Fujirebio Diagnostics, ElevateBio, Takeda, Recipharm Advanced Bio, and Sanofi. Documented outcomes include MSD reducing validation cycle times by 50% and process steps by 46% while replacing three QMS systems, Fujirebio Diagnostics cutting CAPA change control time in half and saving 40% on test script execution, and ElevateBio reducing cycle times by 50% and accelerating manufacturing changeovers.

Core Platform Capabilities

• Single platform for digitalising any validation process, described as no-code and highly configurable to suit individual organisational requirements
• Data integrity and traceability assurance across the entire validation lifecycle
• Real-time audit management with the ability to share documents instantaneously, supporting continuous audit readiness
• Proven reduction in cycle times, protocol completion times, and process steps without compromising quality
• Designed to be easy to use, learn, and adopt across global organisations

Supported Use Cases and Validation Processes

• Equipment validation — ensuring equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements
• Computer system validation (CSV) — ensuring computer systems are validated, tested, and maintained in compliance with applicable requirements throughout their lifecycle
• Commissioning and qualification — covering design, installation, testing, and operation of facilities, systems, and equipment
• Analytical instrument validation — qualification, calibration, and maintenance of analytical instruments to deliver accurate, reliable, and traceable results
• Cleaning validation
• Process validation
• Facilities and utilities validation
• Audit readiness — maintaining continuous compliance and documentation accuracy for regulatory inspections and all forms of audits

Industries Served

• Pharmaceuticals
• Biotechnology
• Medical devices
• Consumer health

Certifications, Accreditations, and Memberships

• Certified to ISO/IEC 27001:2022 (information security management) by the National Standards Association of Ireland (NSAI)
• Certified to ISO/IEC 9001:2015 for quality management system operation
• Platinum member of the International Society for Pharmaceutical Engineering (ISPE)

Company Background and History

• Founded between 2007 and 2011 with a vision to automate validation; co-founded by Eddie Ryan (CEO), Brian Ahearne, and Kevin Fitzgerald, who bring backgrounds in pharmaceutical engineering and software development
• Spent approximately eight years in development and testing before customer delivery, writing over 900,000 lines of purpose-built code
• Publicly listed on the Toronto Stock Exchange (TSX) under the ticker KSI
• Expanded operations to support demand in Europe, the Americas, and Asia
• Holds four consecutive Deloitte Ireland Fast 50 awards
• Launched Kneat Academy for training and education, and hosts an annual validation event called VALIDATE
• Leadership team includes executives with backgrounds in global technology organisations, pharmaceutical engineering, software product development, and international business scaling

Kneat is headquartered in Europe and operates internationally, with 97% of customers rating its customer support as "Very Good" or "Excellent" according to its own reported CSAT data, and a high customer renewal rate reported via SoftwareReviews.com.