Computer system validation software for pharma and life sciences
Kneat is trusted by leading biopharma, CDMOs, and life sciences teams to manage CSV, CSA, and computer system validation end to end.
Digitalize any computer system validation process your way, in one easy-to-use, highly configurable, no-code solution built for GxP environments.
Kneat is proven to deliver unparalleled data integrity, efficiency, audit readiness, and cost savings.
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Kneat Computer System Validation
Compliant, streamlined, audit-ready CSV
Kneat is proven to deliver data integrity, efficiency, and audit readiness to computer system validation teams in pharma and biopharma. From CSV and CSA to GMP computer system validation, Kneat supports every validation type your team runs, with the 21 CFR Part 11 and GAMP 5 compliance controls your QA and regulatory teams require.
Efficiency amid complexity
Computer system validation professionals face rising system complexity, integrations, AI-driven technologies, Industry 4.0, and evolving regulations including GAMP 5 and 21 CFR Part 11. Kneat streamlines CSV and CSA, delivering over 50% cycle time savings across the process lifecycle.
Streamlined change control
Frequent software updates and evolving business needs force validation teams into continuous revalidation cycles, straining resources and increasing compliance risk. Kneat streamlines change control, enabling you to reduce change-assessment turnaround and change-implementation time, while maintaining full audit trail integrity.
Total traceability
Maintaining end-to-end traceability in computer system validation is critical but challenging, with fragmented records making it hard to track requirements, risks, tests, and approvals. Kneat digitalizes and centralizes CSV validation, ensuring complete, real-time traceability and audit readiness across every system and site.
BENEFITS
Built for the complexity of life sciences CSV and CSA
Kneat enables a document or data-centric approach to computer system validation, giving you the flexibility to validate systems your way. Drive efficiency, compliance, and data integrity across complex, evolving computer systems in global and integrated GxP environments, with a platform built for pharma, biopharma, and medical device organisations.
- Cut global CSV deployment costs by 35%, proven with SAP S/4HANA rollouts
- Achieve GAMP 5 CSA with flexibility to scale testing appropriately to risk
- Validate any computer system, 100% remotely, with full 21 CFR Part 11 compliance
- Reduce global system deployment time by up to 18%
- Support both traditional CSV and modern CSA approaches on one platform
It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore.
- Manager IT Compliance, Fujirebio Diagnostics, Inc
MORE EFFICIENT FOR CSV
HCL Technologies achieved a 35% project cost saving deploying SAP S/4HANA for Epredia using Kneat.
ACRCREDITATIONS & MEMBERSHIPS
Book a Computer System Validation Demo
See how Kneat helps pharma and biopharma teams digitalize CSV and computer system validation, cut cycle times by over 50%, and stay audit-ready across every site and system.
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