Kneat Gx

Kneat Gx is a digital validation platform purpose-built for life sciences companies, designed to replace paper-based validation processes with a fully digital, GxP-compliant system. It is used by pharmaceutical, biotechnology, medical device, consumer health, and contract manufacturing organisations to manage the full validation lifecycle — from protocol creation through review, approval, and test execution — within a single configurable platform.

The platform supports both document-centric and data-centric validation approaches, allowing teams to build and manage process flows without writing code. Customer case studies report cycle time reductions of over 50% and validation cost reductions of over 35% following adoption.

Core Capabilities

• Supports any validation process type within one platform, with configurable workflows that do not require coding
• Provides secure, time-stamped audit trails with role-based access controls and automated traceability to support data integrity requirements
• Enables instant document retrieval and audit preparation through dedicated audit readiness features, including audit "war-rooms"
• Harmonises validation processes across multiple sites to support consistent compliance and governance
• Designed for fast adoption with an interface intended to reduce training time and support cross-team collaboration

Supported Use Cases

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

Industry Coverage

• Pharmaceuticals: supports quality assurance and validation teams in addressing compliance and operational challenges
• Biotechnology: handles process, analytical method, equipment, cleaning, computer system, assay, sterilization, and facility validations
• Medical Devices: covers design, process, software, cleaning, equipment, packaging, sterilization, and test method validations
• Consumer Health: improves efficiency across the validation lifecycle to accelerate time to market
• Contract Manufacturing: supports technology transfer, documentation transparency, and faster release to production

Teams That Use Kneat Gx

• Engineering teams use it to streamline commissioning and qualification, maintain equipment integrity, and accelerate delivery timelines
• Quality assurance teams rely on it for data integrity, regulatory compliance, and audit readiness
• IT teams implement it to consolidate multiple point solutions and integrate with existing digital ecosystems
• Quality control teams use it to collaborate on and contribute to validation activities

Documented Customer Outcomes

• Merck Sharp & Dohme (MSD) digitised seven validation processes globally, reducing cycle times by 50%, process steps by 46%, and consolidating from five systems to two
• Biogen digitalised analytical instrument validation as part of a "Lab of the Future" initiative, achieving improvements in efficiency, data integrity, and compliance
• Fujirebio Diagnostics cut CAPA change control time by 50% and reduced test script execution effort by 40%
• ElevateBio reduced cycle times by 50% and accelerated manufacturing changeovers

Kneat Gx is rated by customers on independent platforms including G2.com and SoftwareReviews.com, with 97% of customers rating support as either "Very Good" or "Excellent." The platform is positioned for organisations seeking to replace paper records and fragmented point solutions with a single, compliant digital validation environment.