Transferring ADAPTIV's data into the New Product Template meant reformatting and merging the source documents into the required structure before the template could be called complete.
Data transfer still needs formatting discipline
Moving data into a new template reads as a content task, but the formatting and merging requirements sitting underneath it are just as much a submission requirement as the data itself.
- Comparing the existing checklist/instruction against the current regulation or process in practice
- Correcting discrepancies found while transferring ADAPTIV's data
- Confirming the update against the source document or QMS procedure
What an outdated instruction risks
An outdated checklist or work instruction being followed after the underlying regulation or process has changed applies just as much to a data transfer task as to any other submission work.
What the transfer delivered
Reformatting and merging the documents into the required standard made the ADAPTIV New Product Template package submission-ready.
The Real Takeaway
Formatting and merging documents seems purely cosmetic but is often a submission requirement in its own right.
Getting it wrong is a preventable reason for rejection.