Ensure utility systems are suitable for purpose
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 manages all qualification activities
Kneat manages all qualification activities from requirements through FAT, SAT, DQ, IQ, OQ, PQ Review and ongoing change management:
- 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
- All records centrally managed
- Part 11/Annex 11 environment
Why use Kneat for utilities validation?
By digitizing the entire validation life-cycle, Kneat is proven to deliver significant efficiencies:
- Productivity improvement
- Cycle Time reduction
- Standardization of validation records across projects and sites
- Elimination of paper record storage: access any record in seconds, never misplace another record
- Data Integrity threat minimization: ‘ALCOA’ principles embedded in the process with the focus on the data life-cycle
- Instant micro and macro visibility into all aspects of any validation process, in real time
- On-line test execution eliminates protocol GDP errors
- Comprehensive systems register provides real time inspection preparedness checklist
Client Story: Tier One Biotech
Digitizing the entire validation life cycle: A productivity leap
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