Computer system validation

Computer System Validation (CSV)

Paperless Computer System Validation (CSV)

Good Manufacturing Practice (GMP) requires that you build and operate manufacturing processes that are suitable for purpose, and 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 to support your GMP processes, while IT departments are often resource challenged to maintain existing systems, transition legacy systems, and deploy new systems.

Installing and maintaining computer systems in regulated environments requires a structured approach 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), delivering compelling productivity, cycle-time and compliance improvements across the entire CSV validation life-cycle.  All your CSV activities can be digitized, streamlined and centralized across an unlimited number of sites.

 

 

Manage the entire Computer System Validation life-cycle, with one solution

  • Vendor audit
  • IT system register management
  • Validation master planning
  • Impact assessment
  • Part 11/Annex 11 assessment
  • Validation project management
  • Requirements capture, trace-ability and life-cycle management
  • Risk management
  • Design qualification (DQ), installation qualification (IQ), operational qualification (OQ)
  • User acceptance testing (UAT)
  • Paperless test execution with integrated deviation management
  • Review, change management and re-qualification
  • Part 11/Annex 11 compliant

Why use Kneat?

  • 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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