Process validation

Kneat Gx | Paperless Process Validation

Process Validation

Life Sciences industry regulations require that all processes used to manufacture a drug product be validated and the process as well as the associated systems are 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.

Process Validation is the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a product. Critical Process Parameter and other process data is used in many documents throughout the process validation process. Data can be transferred from site to site or from research and development. This data is critical to the success of the product and must be maintained to ensure a successful product launch and campaign. In addition, data from the process validation is needed in other validation programs such as the Facility, Utility and Equipment Qualification and the Cleaning Validation programs.

 

Paper-based Process 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 Process Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx”, digitizes the entire Process Validation throughout the Product’s 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 simply by 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
  • Design Documents (Critical Process Parameters)
  • Risk Assessment
  • Test protocols (PV)
  • Validation Summary Report
  • Validation Final Report
  • Operational Forms
  • Decommissioning

 

Standard Features and Functionality
  • Critical Requirements and Parameter Manage
  • Requirements Traceability
  • Dynamic Data Sharing
  • Real-time documentation metrics
  • Status Monitoring and periodic review management
  • Template Management and Approval
  • Work Process Management
  • System Register Management

Why use Kneat Gx for Process Validation?

  • Risk-based, lean, life-cycle approach to process validation
  • Productivity improvement of up to 100%* and cycle time savings of up to 50%*
  • Eliminates 100% of paper-records, physical storage and retrieval and associated costs
  • Digitized test-execution with integrated deviation management
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • ‘ALCOA’ Data Integrity best-practice
  • Comprehensive audit trail with detailed, un-editable change log
  • Instant macro and micro visibility into all aspects of the process in real time
  • Protocol based GDP errors minimized
  • System status monitoring – validated, review due/complete, etc.

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