Computer system validation

Ensure your computer systems are in control and fit for purpose

Good Manufacturing Practice (GMP) requires that you build and operate manufacturing processes that are suitable for purpose, that will consistently deliver therapeutic products that meet their pre-defined quality attributes.  This requires that you validate and maintain an ever-increasing number of computer systems that support your GMP processes.  IT departments are resource challenged to maintain existing systems, transition legacy systems, deploy and support new systems.

Installing and maintaining computer systems in regulated environments requires a structured efficient approach throughout the life-cycle from vendor selection, to configuration and acceptance testing through to go live and change management (patching, upgrading, configuration changes).  Kneat is a game changer for computer system validation (CSV).  The Kneat CSV e-solution delivers compelling productivity, cycle time and compliance improvements across the entire life-cycle.  All your CSV activities can be digitized, streamlined and centralized corporate wide.

 

The platform manages every step of the process:

  • Vendor audits
  • IT system register management
  • Validation master planning
  • Impact assessment
  • Part 11/Annex 11 assessment
  • Validation project manager
  • Requirements capture, traceability and life-cycle management
  • Risk management
  • Design qualification, installation qualification, operational qualification
  • User acceptance testing
  • Paperless test execution with integrated deviation management
  • Test leveraging based on risk and good documentation practice
  • Review, change management, requalification
  • Part 11/Annex 11 environment

The benefits are many: from cycle time and cost reductions to quality and compliance

  • Productivity Improvement and cycle time savings
  • Best practice standardized CSV process for all project and IT system life-cycle management
  • Paper records eliminated. Find and launch the correct record in seconds
  • Potential for data integrity issues minimized, ‘ALCOA’ principles embedded in the process. Instantly see why approved data was changed, when and by who
  • Instant macro and micro visibility into all aspects of the process in real time
  • Protocol GDP errors minimized
  • Periodic review management
  • 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

The client, a leading molecular diagnostic company, is 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 for Computer System Validation since 2014.
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