Eliminate the Laboratory process pains & enhance compliance assurance. Through electronic Lab validation enabling significant productivity gains, cycle time improvements and resource savings.
Eddie is CEO and joint founder of Kneat Software Ltd. with almost 30 years’ experience within the Life Science and Pharmaceutical industry.
A qualified mechanical engineer with 15 years within design, production and project management and 10 years’ experience within regulated IT development and business development. He has also managed multidisciplinary pharmaceutical projects on behalf of blue-chip companies.
Increasing levels of Validation activities and higher regulatory expectations across laboratory processes are increasing the demand for compliant Validation services.
The laboratory process for equipment management and status tracking is a manual paper based process, with the following issues:
- High level of effort/ time to create, execute and maintain lab Validation records i.e. requirements, protocols, test scripts, risk assessments, trace matrices
- Cross lab and cross sites inconsistences
- No real time viewable lab equipment/ systems status index
- No standardized/ structured new equipment process templates/ workflows
- No efficient process to leverage previous information for current tasks
- No best practice across projects and sites
- Accurate Metrics not available
- Cumbersome record storage and retrieval
- Limited visibility both globally and across sites
- Data integrity concerns i.e. ALCOA principles
Using an actual client example the workshop will explain:
- from existing paper to a future e-validation solution and the steps to justify, plan implement a lab e-validation system
- Streamline and structured process to identify/ track/ quality new equipment.
- Comprehensive dashboard with visibility to real-time data for lab equipment & systems
- Ability to share and leverage information across labs/ sites
- Ensure compliance with data integrity requirements
- Provide easy controlled lab records e-access and user friendly metrics
- Ability to verify user training before equipment/ system use
Kneat develops and markets the Kneat Gx software platform an e-Validation tool which enables the Life Sciences industry to become fully electronic with their many Validation and testing processes. Kneat streamlines and automates all Validations (Process, Equipment, Computer, Cleaning, Laboratory, Commissioning & Qualification, Equipment Changeover Management, Automation Lifecycle Management, Vendor & Project Turnover Management.)
Our customers are realising significant productivity increases, high cycle time reductions and a higher repeatable compliance standard.