Meeting increased productivity and compliance demands

A Leading Molecular Diagnostics Company
Computer System Validation (CSV)

The client is a leading molecular diagnostic company dedicated to saving and improving lives by discovering and delivering tests across major diseases. They produce their own proprietary software which requires validation and FDA compliance and have been successfully using Kneat since 2014.  


Background & Challenge:

Improve and fully digitize CSV

The client wished to move from a problematic, traditional, paper-based Computer System Validation approach to an electronic one while also improving their overall CSV process. In particular, they wanted to address GDP errors, eliminate the risk of record misplacement, streamline the review and approval process and address validation record management, filing, retrieval and archiving.  During the CSV design phase, the team identified the opportunity to also configure their change management process on the Kneat platform. 


Need & Solution:

End-to-end digitization

Following a solution assessment process and a subsequent vendor evaluation process, the Kneat platform was selected. Some key factors cited were: scope of functionality, ease of use, adaptability, the Windows-like interface (as it would “help with onboarding”) and Kneat’s capability to capture every step of the validation process, including test-execution, without ever going to paper.

Implementation & Result:

Greater productivity, shorter cycle times and a higher compliance standard

The Kneat platform was configured and validated within 8 weeks. The CSV and change management process was set up on the platform and user acceptance testing (UAT) completed within a further month. The complete solution was live within 3 months, including training and all support deliverables. The streamlined paperless CSV and Change Management processes have had a substantial impact on the business by enabling more right-first-time, greater productivity, shorter cycle times and a higher compliance standard.

Specific improvements observed by the client in CSV and Change Management

  • Simplified protocol generation, review and approval (including approvals while traveling)
  • Simplified paperless protocol execution and discrepancy management
  • Simplified protocol post execution review and approval
  • Enabled leveraging and reuse of previous validation information
  • No paper handling, management or storage
  • Reduced deviations, greater right-first-time, greater GDP and data integrity assurance
  • Improved audit preparedness
  • Improved metrics on all aspects of the process e.g. dashboard on real-time validation status based on deliverables complete
  • Improved information access and visibility – validation index, dashboards and records
  • Elimination of many time-consuming manual steps
  • Provided platform to establish simple, effective and compliant Change Management

Implementing the e-Val system and going paperless has enabled us to streamline our work processes and provide a more efficient and effective way to meet the increasing demands of the business for compliance and productivity. We were very gratified when we reviewed the new e-Val system with the regulatory agencies and received very positive feedback on our ability to document, manage, retrieve and track validation data as well as our commitment to best-in-class GxP processes.

Shane Pew, Quality Director, Project Sponsor and Champion, Molecular Genetics

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