Cleaning Validation is the documented process for ensuring cleaning activity removes active pharmaceutical ingredients (API), cleaning aids used in the cleaning process itself and other potential contaminants from equipment and components used in the manufacturing process.
Cleaning Validation is required to be performed per a cleaning schedule, as appropriate for the nature of the drug, process, equipment, and facility to ensure the requirements of 21 CFR 211.67 are met. Cleaning Validation is governed by FDA 21 CFR 211.67 Equipment Cleaning and Maintenance, and 211.180 and 211.182, and EudraLex Annex 15.
Documenting the cleaning validation process on paper, can result in significant inefficiencies including, difficulty determining cleaning validation status of equipment and components, inefficient changeover and cycle times, non-value-added activities at protocol level, lack of data visibility across disparate records, physical record retrieval and storage and even record loss.
Kneat Gx | Paperless Cleaning Validation
Kneat Solutions’ next generation paperless validation software “Kneat Gx” delivers compelling productivity, cycle-time and compliance improvements across the entire cleaning validation life-cycle.
- Cleaning validation plan/program for manual or automatic clean-in-place systems (CIP)
- Standard operating procedure (SOP)
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Cleaning validation reports
Why use Kneat Gx for Cleaning Validation?
- Risk-based, lean, integrated, best-practice life-cycle approach to cleaning validation
- Reduce changeover time by up to 50%* in multi-product facilities
- 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.
Client Story: A global life sciences company
Efficiency, control, traceability and insight
Request A Demo
Talk to us
Find out how Kneat can make your validation easier, faster, and smarter.
Start your paperless validation revolution by speaking to our experts.