Laboratory instrument validation
Instrument selection, validation and change
Life Sciences industry regulations require laboratory equipment to be validated and maintained under change control for their full lifecycle. Failure to demonstrate a state of control can result in regulatory citations, fines, product recall and risk to product license. The typical business process to comply with the regulations is a manual, paper-based process that is inefficient, time consuming, labour intensive and susceptible to data integrity and compliance risks. This paper-based process does not scale and does not support cross site alignment such as leveraging processes and sharing of information.
Kneat’s analytical instrument lifecycle management solution will digitize and simplify this process, assure continuous compliance, increase productivity by up to 100% and cut cycle times by up to 60%.
Kneat manages all your analytical instrument validation activities:
- Validation master plan management
- Systems Register management
- System Impact assessment
- Requirements capture and traceability management
- Risk assessment
- Test protocol development (FAT, SAT, IQ, OQ, PQ/UAT)
- Paperless test execution with integrated deviation management
- Validation summary final report
- Real time validation metrics
- Validation status monitoring and periodic review management
- Part 11/Annex 11 environment
The benefits are many from cycle time and cost reductions to quality and compliance assurance improvements:
- Productivity Improvement and cycle time savings
- Best practice that can be leveraged over and over across projects and sites
- Paper records are eliminated – instant central access to all records online
- Records and versions cannot be misplaced – find and launch the correct record in seconds
- Potential for data integrity issues is minimized, ‘ALCOA’ principles embedded in the process with focus on the data lifecycle
- Instant macro and micro visibility into all aspects of the process in real time
- Protocol GDP errors minimized
- Comprehensive validation register provides real time inspection preparedness
Client Story: Biogen Inc.
Biogen's Lab of the Future
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