Laboratory instrument validation
Paperless Lab Instrument Validation
Life Sciences industry regulations require laboratory equipment to be validated and maintained under change control for their full life-cycle. 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, labor 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 life-cycle 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%.
Manage the entire Analytical Instrument Validation life-cycle:
- Validation master plan management
- Systems Register management
- System Impact assessment
- Requirements capture and trace-ability 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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