Description
- How digital validation tools are enabling validation 4.0
- Risk based data integrity processes (importance of data mapping and criticality of data)
- Building in Data integrity by design into digital validation systems
- Data integrity guidance watchouts – Bring paper into the digital world compliantly and defining “true copy” practices
- How to create the digital workforce of the future
- Enabling digital validation education
- AI , machine learning ,and system integration – How can the be harnessed to enable validation 4.0 and a digital validation ecosystem ?
- Differences between AI /Machine learning – how do they impact validation strategy
- AI how can it be used to enable validation 4.0 and dynamic documentation
- Live example of tool
- Interfacing key data systems for digital validation ,and creation of data flowsDiscussion on the changing world of validation (pharma 4.0 / validation 4.0) and the hot topics of the moment . How do we create a digital validation ecosystem ,create data integrity by design, and harness digital validation tools and emerging technologies such as API’s /AI /ML to create dynamic validation data to enable validation 4.0 principles.
Takeaway Tools
- Scenarios of how to treat static and dynamic data based on risk for “true copy”
- Demonstration of AI LLM tool for creation of digital validation documentation
