UC-418
Tech Transfer and Validation Evidence
Maps the sending site's process against the receiving site's equipment, lists the gaps, and assembles the process validation evidence pack.
TBDBuild Duration
XXXXIndicative ROI
XXXXBuild Cost
XXXXValue
The Challenge
Moving a process to a second site takes months because equipment differences surface during validation runs rather than before them. Development reports, site SOPs and equipment files sit in separate systems.
How It Works
- Reads development reports, master batch records, site SOPs and equipment qualification files.
- Maps each parameter to receiving-site equipment and scores where a proven range breaks.
- Hands the transfer team a gap list and drafted validation protocol before the first run.
What It Removes
- Manual equipment-to-equipment comparison spreadsheets
- Rebuilding the risk assessment from a blank template
- Hunting development reports for the parameter basis
Input Data RequirementsDevelopment and characterisation reports, master batch records, site SOPs, equipment qualification files, change controls, validation protocols
Output FormatSite-to-site process gap list, drafted process validation protocol and rationale, parameter traceability table back to the development data
“We find out the new site's dryer behaves differently on the third validation batch, not in the transfer plan”