Utility Validation &
Facility Validation

Traditional paper-based utilities commissioning and qualification processes are inefficient and susceptible to data integrity and compliance risks.

Documented impact assessments should be performed on all utility systems (waters, steam, air, process gases, HVAC and others).  Those that may have an impact on product quality should be appropriately qualified in accordance with Good Manufacturing Practice.

Qualification requirements may include both equipment and process perspectives and supporting documentation may include both qualification and/or commissioning activities. Qualification should be supported by a Design Review (DR) along with reference to engineering standards and design drawings. A risk-based approach that utilizes test leveraging such as ASTM E2500 may also be used, as long as all testing is suitably documented and is still relevant at go-live.

Qualification data and deliverables may be provided by vendors of the utility system in support of the overall qualification. Post start-up, a robust change control process is essential to maintain the validated state of all utilities.

Kneat Gx | Paperless Utility and Facility Validation

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

Functions

• Validation Master Plan management
• Design Review
• Requirements capture and management
• Risk assessment management
• All protocol development and management
• Document review and approval
• Paperless test execution with integrated deviation management
• Qualification summary report
• Real time qualification status and metrics
• Periodic review
• Change management and re-qualification

Why use Kneat Gx for Utility and Facility validation?

By digitizing the entire validation life-cycle, Kneat is proven to deliver significant efficiencies:

• ASTM E2500 best practice method
• Facilitates best practice risk-based, lean, life-cycle approach to validation
• Eliminates 100% of paper-records
• Productivity improvement of up to 100%*
• 21 CFR Part 11/EudraLex Annex 11 compliant
• Standardization of validation records across projects and sites
• ‘ALCOA’ Data Integrity best-practice
• Instant macro and micro visibility into all aspects of the process in real time
• On-line test execution eliminates protocol GDP errors
• System status monitoring – validated, review due/complete, etc.
• Audit ready in real time