The situation
Audit evidence was assembled from binders, shared drives and email. A routine GMP request took the quality team three days to collate.
What we did
- iDMS capture from scanners and controlled mailboxes.
- Classification of certificates, batch records and deviations, linked to the SAP order.
- A retention and approval trail a reviewer can open from the document itself.
What changed
Preparing evidence for an audit request dropped from three days to about two hours, because the document was already on the transaction.