Computer System Validation
Kneat Gx | Paperless Computer System Validation and Verification
Computer Software Validation and Verification is a standardized process for testing computer software and systems, mandated by FDA 21 CFR 11.10(a) and EudraLex Annex 11, Section 4 regulations for electronic data management systems.
Installing and maintaining computer systems in regulated environments requires a structured life-cycle approach, from vendor selection, to configuration and acceptance testing through to go-live and change management (patching, upgrading, configuration change).
As Life Sciences manufacturers seek efficiencies in manufacturing processes through computer systems, demand to install and maintain an array of increasingly complex computer systems and software grows – as does their risk profile.
Kneat Gx | Paperless Computer System Validation
Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire computer system validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements.
Audits and assessments
- Computer System Vendor audit
- 21 CFR Part 11/EudraLex Annex 11 assessment
- Impact assessment
Validation and Verification
- Validation master planning
- Validation project management
- Functional Specification (FS), Design Specification (DS)
- Design qualification (DQ), installation qualification (IQ), operational qualification (OQ)
- User acceptance testing (UAT)
- User Requirements Specification (URS)
- Requirements capture, traceability and life-cycle management
- Periodic review management
- IT System rRisk managementegister management
- Risk management
- Review, change management and re-qualification
Why use Kneat Gx for Computer System Validation and Verification?
- Facilitates best practice risk-based, lean, life-cycle approach to validation
- Eliminates 100% of paper-records
- Paperless test execution with integrated deviation management
- Productivity improvement of up to 100%* and cycle time savings of up to 50%*
- 21 CFR Part 11/EudraLex Annex 11 compliant
- Standardizes CSV processes for all project and IT system life-cycle management
- ‘ALCOA’ Data Integrity best-practice
- Instantly see why approved data was changed, when and by who
- Macro and micro visibility into all aspects of the process in real time
- Protocol GDP errors minimized
- System status monitoring – validated, review due/complete, etc.
- Audit ready in real time
Client Story: A Leading Molecular Diagnostics Company
Meeting increased productivity and compliance demands
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