Kneat Gx is a proven digital validation platform designed to significantly improve efficiency and reduce compliance risk for organizations within the life sciences industry. As the only digital validation platform capable of handling any process, it offers unparalleled flexibility, allowing users to configure workflows their way, whether adopting a document-centric or data-centric approach. The platform ensures robust data integrity with automated, tamper-proof records, guaranteeing complete accuracy, compliance, and security. Its intuitive design promotes fast adoption and ease of use, empowering teams to navigate, collaborate, and validate with efficiency. Kneat Gx enables businesses to create, manage, and optimize validation workflows without requiring code, seamlessly integrating across various operations. Key benefits include substantial reductions in cycle times, often by over 50% across the validation lifecycle from protocol creation to test execution, and significant cost savings, with reported reductions exceeding 35%. The platform also enhances audit readiness by providing complete traceability and instant document retrieval, ensuring continuous compliance and preparedness for regulatory inspections. It supports harmonization and governance across validation processes, making it a comprehensive solution for biotechnology, pharmaceuticals, medical devices, and consumer health sectors.

Features & Benefits

• Flexible & Configurable Validation
  • The only digital validation platform for any process, configurable to user needs. Supports both document-centric and data-centric approaches, allowing users to build and manage process flows as required, whatever their validation methodology.
• Unparalleled Data Integrity
  • Ensures complete accuracy, compliance, and security with robust data integrity controls and automated, tamper-proof records.
• Ease of Use & Adoption
  • Intuitive design drives fast adoption, reducing training time and empowering teams to navigate, collaborate, and validate with ease.
• Efficiency & Cycle Time Reduction
  • Reduces cycle times in every step of the validation lifecycle, from protocol creation to review, approval, and test execution, with reported reductions of over 50%.
• Cost Savings
  • Reduces validation costs, with reported savings of over 35% as found in customer case studies.
• Audit Readiness
  • Maintains a state of continuous compliance and documentation accuracy, ensuring preparedness for regulatory inspections and all forms of audits with complete traceability and instant document retrieval.
• Harmonization & Governance
  • Facilitates consistent validation processes and oversight across the organization.
• Comprehensive Validation Use Cases
  • A single platform supporting a wide range of validation needs.
  • Analytical Instrument Validation
  • Audit
  • Cleaning Validation
  • Commissioning & Qualification
  • Computer System Validation (CSV)
  • Equipment Validation
  • Facilities & Utilities Validation
  • Process Validation