Cold chain validation

Kneat Gx | Paperless Cold Chain Validation

Pharmaceutical Supply Chain, Temperature Controlled Storage Validation
Cold Chain Validation, Transport Validation

Cold Chain is a temperature controlled supply-chain, involving the transportation and storage of medicinal products continuously at temperatures within a set range, typically between 2°C and 8°C or lower, depending on product requirements and regulatory jurisdiction.

In order to comply with regulatory guidance, Bio-Pharma products must meet specific, required storage conditions identified in stability studies and maintain these during shipping and distribution. 

Monitoring, refrigeration, storage, transportation equipment and distribution routes involved in the cold chain must be qualified and validated to assure compliance and ensure that product quality will not be adversely affected. 

As the complexity of the development of cold chain biologics and clinical trials increases, so has the need for greater efficiencies and risk minimization in cold chain validation. Typical validation processes remain paper-based making them inefficient, labour intensive and susceptible to data integrity and compliance risks.

 

Kneat Gx | Paperless Cold Chain Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire cold chain validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements. 

 
Functions
  • Validation plan management
  • Systems register management
  • System impact assessment
  • Requirements capture and management
  • Risk assessments
  • Requirements trace-ability matrix
  • Test protocol development (IQ, OQ, PQ/UAT)
  • Paperless test execution with integrated deviation management
  • Validation summary final report
  • Real time validation metrics
  • Validation status monitoring and periodic review management

Why use Kneat Gx for Cold Chain Validation?

  • 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%*
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • ‘ALCOA’ Data Integrity best-practice
  • Instant 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

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