This is a ready-to-use log. Replace every <<FILL: ...>> placeholder with your own specifics and maintain it under your document control system. A worked filled specimen follows the template. It is an educational aid to adapt and verify, not a compliance guarantee.
Log control
| Field | Format | Required | Completed by | When |
|---|---|---|---|---|
| Document number and version | Text | Yes | Document control | At each issue |
| Copy number | Sequential | Yes | Document control | At issue |
| Holder and location | Text | Yes | Document control | At issue |
| Issue date | Date | Yes | Document control | At issue |
| Retrieval / destruction date | Date | Yes at revision | Document control | At retrieval |
Purpose
Let the firm state, at any moment, exactly how many controlled copies of a document exist and where each one is. When a copy cannot be accounted for, an obsolete version can survive in use until an inspector finds it. This log is the control that prevents that.
Instructions
- Record every controlled copy issued for use at the bench or in the suite, with a unique copy number, holder, and location.
- Distinguish a controlled copy (stamped or otherwise marked, tracked here) from an uncontrolled printout (marked “uncontrolled if printed”), which is never logged.
- At each revision, retrieve every controlled copy of the superseded version, confirm destruction, and record the destruction date before distributing the new version.
- Reconcile the log at each revision: copies issued must equal copies retrieved and destroyed plus copies reissued.
Register
| Doc no. and version | Copy no. | Holder / location | Issue date | Issued by | Retrieval / destruction date | Reconciled by |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every controlled copy in circulation appears in the register with a unique number, holder, and location.
- At each revision, every copy of the superseded version is retrieved and its destruction recorded before the new version is distributed.
- The reconciliation closes: issued equals retrieved-and-destroyed plus reissued, with no unaccounted copies.
- Uncontrolled printouts are visibly marked and never mistaken for controlled copies.
Retention
Retain per the records retention schedule, for not less than <<FILL: retention period>>.
References
21 CFR 211.100(b) (procedures followed and documented at the time of performance) and 211.180 (retention). EU GMP EudraLex Volume 4, Chapter 4, Documentation (controlled distribution and retrieval of superseded documents). ISO 13485:2016 clause 4.2.4 (control of documents, including preventing use of obsolete documents), for operations following that standard.
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (QA) | <<FILL>> |
Filled specimen
A register worked through a revision from Rev B to Rev C of an SOP:
| Doc no. and version | Copy no. | Holder / location | Issue date | Issued by | Retrieval / destruction date | Reconciled by |
|---|---|---|---|---|---|---|
| SOP-QC-058 Rev B | 01 | QC lab, HPLC bench | 10 Jan 2026 | D. Cho | 04 Apr 2026, destroyed | D. Cho |
| SOP-QC-058 Rev B | 02 | QC lab, wet chemistry | 10 Jan 2026 | D. Cho | 04 Apr 2026, destroyed | D. Cho |
| SOP-QC-058 Rev B | 03 | Fill suite anteroom | 10 Jan 2026 | D. Cho | 04 Apr 2026, destroyed | D. Cho |
| SOP-QC-058 Rev C | 01 | QC lab, HPLC bench | 04 Apr 2026 | D. Cho | in use | D. Cho |
| SOP-QC-058 Rev C | 02 | QC lab, wet chemistry | 04 Apr 2026 | D. Cho | in use | D. Cho |
| SOP-QC-058 Rev C | 03 | Fill suite anteroom | 04 Apr 2026 | D. Cho | in use | D. Cho |
At the revision, three Rev B copies were issued and three were retrieved and destroyed on the effective date, and three Rev C copies were issued. The reconciliation closes, so there is no risk of a Rev B copy surviving in the suite.
Common inspection findings this log prevents
- An obsolete copy left at a workstation because it was never retrieved at the revision.
- The firm unable to state how many controlled copies exist and where.
- Uncontrolled printouts treated as if they were controlled, or the reverse.
- A revision distributed before the superseded copies were reconciled.
How to adapt this log
- Match the copy-marking mechanism to your system (a colored stamp with a copy number, or an EDMS watermark with a print date).
- Set the reconciliation step into your revision workflow so copies are retrieved before the new version distributes.
- Point the retention line at your records retention schedule.
- Confirm each reference against its current published version before issue.