Computer System Validation
and Verification

Life Sciences industry regulations require that all critical computer systems used for the manufacturing, storage, or testing of a drug product be validated and maintained in a validated state throughout the computer system’s life cycle. Failure to demonstrate a state of control can result in regulatory citations, fines, product recall and risk to product license.

Computer Software Validation and Verification is a standardized process for testing computer software and systems, mandated by FDA 21 CFR 11.10(a) and EudraLex Annex 11, Section 4 regulations for electronic data management systems. Installing and maintaining computer systems in regulated environments requires a structured life-cycle approach, from vendor selection, to configuration and acceptance testing through to go-live and change management (patching, upgrading, configuration change). As Life Sciences manufacturers seek efficiencies in manufacturing processes through computer systems, demand to install and maintain an array of increasingly complex computer systems and software grows – as does their risk profile.

Paper-based Computer System Validation and Verification

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 Computer System Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire computer system validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements. Kneat Gx allows you to manage all your computer system’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, etc.)
• Risk Assessment
• Test protocols (FAT, SAT, IQ, OQ, PQ/UAT, etc.)
• 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

Audits and assessments

• Computer System Vendor audit
• 21 CFR Part 11/EudraLex Annex 11 assessment
• Impact assessment

Validation and Verification

• Validation master planning
• Validation project management
• Functional Specification (FS), Design Specification (DS)
• Design qualification (DQ), installation qualification (IQ), operational qualification (OQ)
• User acceptance testing (UAT)
• User Requirements Specification (URS)
• Requirements capture, traceability and life-cycle management

Validation Management

• Periodic review management
• IT System Risk management
• Register management
• Risk management
• Review, change management and re-qualification