Commissioning and Qualification Validation (CQV)
Kneat Gx |Paperless Commissioning and Qualification Validation
Commissioning Verification and Validation
Commissioning and Qualification (CQV) are early phases of the validation life cycle of manufacturing facilities, utilities, systems and equipment. Under Current Good Manufacturing Processes (CGMP), Commissioning and Qualification must precede the manufacture of products at commercial scale, and subsequent Process Validation procedures.
Commissioning is the systematic, documented approach to the start-up and turnover of facilities, utilities, systems and equipment, to ensure design requirements and user requirements are met. While Qualification is the systematic, documented approach to demonstrating that facilities, utilities, systems and equipment are suitable for their intended use and perform properly.
Commissioning and Qualification validation processes are governed by various FDA and EudraLex regulations, specific to the subject of their process (facility, utility, systems, equipment). Documenting the Commissioning & Qualification process on paper, can result in significant inefficiencies including an inability to adequately enforce process requirements, non-value-added activities, lack of data visibility, physical record retrieval and storage and lengthy cycle times.
Kneat Gx | Paperless Commissioning & Qualification Validation
Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire Commissioning and Qualification Validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements.
- Master plan/Commissioning plan
- System Specification: User Requirement Specification (URS), Functional Requirements Specification (FRS), Design Specification (DS)
- Pre-commissioning: Factory acceptance testing [FAT] and Site acceptance testing [SAT]
- Commissioning test and inspection plans (design review, approval and test execution)
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
Why use Kneat Gx for Commissioning and Qualification?
- ASTM E2500 best practice method
- Risk-based, lean, life-cycle approach to commissioning and qualification
- Productivity improvement of up to 100%* and cycle time savings of up to 50%*
- 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 Risk-Focused Global Biotech
Transforming Traceability: From Prohibitive to Productive Risk Mitigation
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