The document discusses how validation processes will change between 2025 and beyond due to disruptive technologies like automation, artificial intelligence, and big data. Key changes include: 1) Automation will execute validation activities like testing and data collection with greater precision than humans. Automated systems will analyze data to monitor processes. 2) Massive amounts of data will be collected and analyzed in real-time to enable predictive process adjustments and system corrections. 3) Validations will become continuous and real-time rather than periodic, relying more on automated oversight and less on human activities. Requirements will be fulfilled rapidly through integrated development, manufacturing, and quality data.

1. The Future of Validation
2025 and Beyond
Steven Mattos

2. A Story of
Change and
Disruption
• Technology
• Automation
• Data
• Development
• Manufacturing
• Quality
• Regulatory
• Commercialization
• Workforce

3. Technology
• Logarithmic computing power
• Seamless system integration
• Bioinformatics based decisions
• A.I. Software driven systems
– people code SW
– people code SW to test SW
– SW codes SW to test SW

4. Automation
• Advanced expert systems executing activities
with better than human precision and
accuracy
• Automated execution of processes, testing
and collection of data
• Automated analysis of collected data for
specification/workflow generation for
monitoring and control of systems

5. Data
• Deluge of data
• Advanced and faster methods of collection,
sorting, analysis, results, reintegration
• Similar bioinformatic processes for big data
management
• Predictive data analysis and systems
correction

6. Development
• Early specification development and capability
analysis
• Faster iterative development and test cycles
• Seamless development/transfer/manufacturing
cycle
• Auto adjustment of process variation to process
input for supplied materials
• Design for manufacturability standardized
• Real time design transfer activities

7. Manufacturing
• More complex systems with less complex
interfaces
• Increased automation systems for suppliers,
processes, products
• Automated process manufacturing
adjustments on processes big data outputs
• Higher volume management

8. Quality
• More focus of automated systems and data
regulation, less human operations and error
• Continuous real-time quality verification versus
periodic reviews
• Reduced commercialization readiness pressures
• Vast reduction of final testing and increase in
process monitoring

9. Regulatory Compliance
• Regulatory harmonization and translation
facilitating faster adoption and implementation
of controls
• System generated updates of regulatory
requirements
• Automated update integration and notification
into the (E)QMS

10. Commercialization
• Advanced quality products
• Cleaner field service interfaces with data
linkage from development and manufacturing
• Validations correlating product performance
to Quality System data output

11. Workforce
• Operations, big data, SW, engineering
technology requirements
• “Big Picture” software and data specialist
• Expert systems management/monitoring
• Data flows/integration management
• A.I self-maintenance requiring technician and
technical manager oversight

12. Validation 2025+
• Real time and continuous
• Limited human activities
• Process oversight oriented
• Rapid requirements fulfillment with
development/manufacturing data integration
• Automated high level diagnostics from A. I.
learning systems

13. The Future of Validation
[Luke Skywalker:] “I can’t believe it.“
[Yoda:] “That is why you fail.”
-Yoda