Cold chain validation

Kneat Gx | Paperless Cold Chain Validation

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

Life Sciences industry regulations require that all critical systems and equipment used in the cold chain logistics (packaging, storage, and distribution) be validated and maintained in a validated state throughout the product’s life cycle. Failure to demonstrate a state of control can result in regulatory citations, fines, product recall and risk to product license.

Cold Chain Logistics 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, the life sciences industry 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, labor intensive and susceptible to data integrity and compliance risks.


Paper-based Cold Chain Validation

The typical work process used to create, execute, and store documents required to comply with the regulations is a manual, paper-based work process that is inefficient, time consuming, labor intensive, not easily scalable, and susceptible to data integrity issues and compliance risks. The paper-based work process is inefficient and time consuming because it requires manual transposition of data from one document to another, the physical movement of the paper documents, limited access to document information and status, and the physical storage of the document during execution and final archival.

The paper-based work process relies on a physical document therefore it cannot be easily scaled for optimal efficiencies. The paper-based work process is also susceptible to poor GDP practices and data integrity, since it relies solely on integrity and skills of the person performing the execution. In addition, printed documents can be lost or damaged during execution, which will result in lost productivity and re-work.


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.

Kneat Gx allows you to manage all your product’s life cycle starting with requirements and critical process parameters through to Validation Final Reports in one easy-to-use application. Documentation generation is simplified in Kneat Gx by pre-approved templates and dynamic data sharing, which reduces time required to generate a document and reduces the human errors by eliminating the need to transpose data between documents. Additional efficiencies are gained since the Kneat Gx work process does not require the transporting of physical documents and these documents cannot be lost or damaged. Paperless execution reduces GDP errors and improves data integrity by providing standard functionality that supports ALCOA principles. In addition, Kneat Gx supports global harmonization and standardization to further reduce time required to deploy a new instrument or the time out of service for changes or upgrades.

The Kneat Gx platform’s built-in validated features and functions support all types of documentation and can be easily set-up up to meet your company’s specific requirements without the need to purchase additional software or modify the application. Changes to deployed work processes or addition of new work processes to Kneat Gx can be performed by a trained user within your organization by simply using Kneat Gx’s standard validated features. These changes can be performed with minimal verification without introducing risk to your program.


Sample Document Types
    • Validation Master Plan
    • System Impact assessment
    • Design Documents (URS, FS, DDS, CS)
    • Design Documents (URS, FS, DDS, CS)
    • Test protocols (FAT, SAT, IQ, OQ, PQ/UAT)
    • Validation Summary Report
    • Validation Final Report
    • Operational Forms
    • Logbooks
    • Decommissioning


Standard Features and Functionality
    • Requirements Manage
    • Requirements Traceability
    • Dynamic Data Sharing
    • Real-time documentation metrics
    • 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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