Analytical Instrument Validation

Life Sciences industry regulations require laboratory analytical instruments be validated and maintained in a validated state throughout the instrument’s life cycle. Failure to demonstrate a state of control can result in regulatory citations, fines, product recall and risk to product license.

Validation requirements may include instrumentation, computer system validation, test method and perspectives, with supporting documentation required from both system owner testing and vendor performed tests. Validation data and deliverables may also be provided by vendors of the analytical instrument in support of the overall validation. Post start-up, a robust change-control process is essential to maintain the validated state of all analytical instruments and their associated computer systems.

Paper-based Analytical Instrument 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 Analytical Instrument Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes all documents required for the entire Analytical Instrument Validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements.

Kneat Gx allows you to manage all your analytical instrument’s life cycle starting with user requirements 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) Risk assessment
• Test protocols (FAT, SAT, IQ, OQ, PQ/UAT)
• Validation Summary Report
• Validation Final Report
• Operational Forms
• Logbooks
• Decommissioning

Standard Features and Functionality

• Requirements Management
• 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 Instrument Validation?

• Reduce cycle-times by up to 60%
• Productivity improvement of up to 100%*
• 21 CFR Part 11/EudraLex Annex 11 compliant
• Eliminates 100% of paper-records
• Best practice that can be leveraged over and over across projects and sites
• Paper records are eliminated – instant central access to all records online
• Records and versions cannot be misplaced – find and launch the correct record in seconds
• Potential for data integrity issues is minimized, ‘ALCOA’ principles embedded in the process with focus on the data lifecycle
• Instant macro and micro visibility into all aspects of the process in real time
• Protocol GDP errors minimized
• Comprehensive validation register provides real time inspection preparedness