Most plants move from paper to electronic batch records in phases. One area goes live first; others keep paper while operators are trained or equipment is brought into scope. The risk during that period is paper that floats free of the electronic record: extra copies, missing pages and entries that never make it back into the system. Data-integrity guidance from regulators expects hybrid systems to be controlled as carefully as fully electronic ones.
How Swat iQua Suite controls the paper side
A controlled copy is issued against a batch that is in progress, on hold or completed. Issuing it flags the batch as a hybrid record. The copy is printed once from the system as a controlled-copy PDF, and that print freezes a checksum of the content. If someone needs the copy again, the system refuses a re-print: the existing copy must come back and a new one is issued, with its own number. A copy issued in error that has never been printed can be removed, but only with a mandatory remark.
When the paper copy returns, it is recorded as returned and then reconciled against the electronic batch record, with a note explaining what was checked. Only then does the batch-close gate in the eBMR clear. QA finally archives the copy with an e-signature. Every transition is in the audit trail, and each step is refused unless the copy is in the right state.
Where it fits
- Plants rolling out the eBMR area by area, with paper in the areas not yet live.
- Steps that still need a wet-ink record for local reasons during transition.
- Sites that want every paper copy accounted for during an inspection.
The hybrid batch record is an option you switch on per site. When every area is electronic, you simply stop issuing copies.