Archiving · Retention · Signed restore
GxP record archiving with a manifest of what was archived.
Archive and restore records with signatures and a register.
E-signed archive with reason
Archiving asks for a reason and an electronic signature with meaning, exactly like any other GxP action.
Complete Child-Record Manifest
Each archive captures which child rows travelled with the parent — signatures, audit entries, batch children — and their counts, so completeness is…
Searchable Archive Register
Every archive set in one list: record type, label, reason, who archived it, when, child-row count, status and the signature reference.
What goes wrong today4 common problems
Archiving is a flag, not a record
Most systems set an archived date with a free-text reason. There is no signature, no manifest of what went with the record, and no way to show the archive was complete.
Nobody can list what has been archived
Without a register, the only way to find archived data is to know it existed. That is not an answer to a retention question.
Restore is an IT job with no audit trail
Bringing a record back typically means a database operation, which is precisely the intervention data-integrity guidance tells you to eliminate.
Retention periods are tracked in spreadsheets
Predicate-rule retention differs by record type and market.
Everything V5 does here5 capabilities
E-signed archive with reason
Archiving asks for a reason and an electronic signature with meaning, exactly like any other GxP action. The signature is bound to the archive set, not just written to a log line.
Complete Child-Record Manifest
Each archive captures which child rows travelled with the parent — signatures, audit entries, batch children — and their counts, so completeness is provable rather than assumed.
Searchable Archive Register
Every archive set in one list: record type, label, reason, who archived it, when, child-row count, status and the signature reference. Filter by record type and status.
Signed Restore on the Same Record
Restoring needs its own reason and e-signature, and is written back onto the same archive set — so archive and restore read as one auditable lifecycle instead of two disconnected events.
Per-Set Manifest Export
Download the manifest for any archive set as CSV or PDF for assessors, migrations and retention reviews.
Standards Referenced
- 21 CFR Part 11 §11.10(b), (c), (e) (accurate copies, record protection, audit trail)
- 21 CFR 211.180 (general record retention requirements)
- EU GMP Chapter 4 (documentation and retention)
- EU GMP Annex 11 §17 (archiving)
- MHRA GxP Data Integrity Guidance (2018)
Common questions5 answers
- What is GxP record archiving software?
- It moves regulated records out of active use without losing their integrity: the archive is signed, the child records that belong to the parent travel with it under a manifest, the set is listed in a register, and restoring it is itself a signed, audited action.
- How do you prove an archived record is complete?
- Each archive set stores the manifest of child tables and row counts captured at archive time — signatures, audit entries and batch children — which can be exported as CSV or PDF and compared against the restored record.
- Can archived records be restored?
- Yes. Restore requires a reason and an electronic signature, and is recorded on the same archive set with who restored it and when, so archive and restore stay on one auditable record.
- Does archiving delete anything?
- No. Archiving removes a record from active lists; it does not delete data. Audit trails and signatures remain intact and retrievable throughout the retention period.
- How does this help with data migration or system retirement?
- The register plus per-set manifests give you a verifiable inventory of what exists, what it contains and who signed for it — the evidence base a migration or decommissioning protocol has to reference.