This is a ready-to-use register for recording certified true copies. It is the single place an inspector or auditor can go to see that a given original was copied faithfully, verified, certified, and, where relevant, retired under control. Replace every <<FILL: ...>> placeholder, keep one row per certified copy (or per certified batch of copies), and maintain the register under document control. A field-definition table, the blank register, instructions, retention, and a filled specimen follow. Verify each cited source against the current version. This is general guidance to adapt, not legal or regulatory advice. This register captures the certification step of the SOP: True Copy Generation, Verification, and Certification.
Why this register exists
A true copy is only defensible if you can show, later, that it was verified and certified before any original was retired or relied on. A scattered set of certification statements filed with each record does not answer “show me every original you replaced with a copy and prove each copy was verified.” A register does. It also lets QA confirm that no original was destroyed without a preceding certification, which is one of the most serious findings in this area.
Field definitions
| Field | Format | Required | Who enters | Definition |
|---|---|---|---|---|
| Register ID | Text (e.g. TCR-YYYY-NNNN) | Yes | Certifier | Unique identifier for this certification entry. |
| Date certified | Date | Yes | Certifier | The date the copy was certified (must predate any original destruction). |
| Original identity | Text | Yes | Certifier | Document number, batch, study, sample, or project that identifies the original. |
| Record type | Static / Dynamic | Yes | Certifier | Whether the original is static or dynamic. |
| Media / target | Text | Yes | Certifier | Media or system the copy was made into. |
| Copy method | Text | Yes | Certifier | Manual scan, or the named validated export/migration process. |
| Verification evidence | Text | Yes | Certifier | Comparison record, checksum/hash result, record count, reprocess test result. |
| Certified by | Name / process | Yes | Certifier | The person or the validated process that certifies the copy. |
| QA review | Name, date | Yes | QA | QA review of the certification (especially for electronic batches). |
| Original disposition | Retained / Archived / Destroyed | Yes | Certifier | What happened to the original after the copy. |
| Destruction authorization | Ref / N/A | Conditional | QA | The authorization reference if the original was destroyed. |
Blank register
| Register ID | Date certified | Original identity | Record type | Media / target | Copy method | Verification evidence | Certified by | QA review | Original disposition | Destruction auth |
|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Static / Dynamic>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Retained / Archived / Destroyed>> | <<FILL: ref or N/A>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions
- Create one entry per certified copy, or per certified batch when a validated process copies many records at once (record the count in the verification evidence).
- For a dynamic original, the verification evidence must include an integrity check (checksum or hash) and a reprocess sample test, not just a visual comparison.
- The date certified must be on or before any original destruction date. If original disposition is Destroyed, the destruction authorization reference is required and its date must be after the certification.
- Do not backfill. Enter the certification when it happens, so the register itself is a contemporaneous, attributable record.
- QA reviews entries on a defined cycle to confirm no original was destroyed without a preceding certification.
Retention
Retain the register under document control for not less than <<FILL: retention period, at least the longest retention of any record it certifies>>. The register outlives the individual copies it certifies, because it is the evidence that each copy was defensible.
Filled specimen
| Register ID | Date certified | Original identity | Record type | Media / target | Copy method | Verification evidence | Certified by | QA review | Original disposition | Destruction auth |
|---|---|---|---|---|---|---|---|---|---|---|
| TCR-2026-0087 | 18 Jul 2026 | CDS project ARCHIVE-2021-Q3, HPLC-07, 1,284 files | Dynamic | Vendor-neutral archive store | Validated export ARC-EXP v3.2 | SHA-256 match 1,284/1,284; 25-file reprocess test passed | Process ARC-EXP v3.2 + M. Okafor | M. Okafor, 19 Jul 2026 | Archived (source retired) | N/A |
| TCR-2026-0088 | 20 Jul 2026 | Analytical Worksheet WS-2026-0412, Batch B-77310, pp. 1-4 | Static | Scanned PDF in QC archive | Manual scan | Page-by-page comparison, complete and legible | A. Patel (verifier: L. Duarte) | R. Gomez, 21 Jul 2026 | Retained in QC archive box QC-A-219 | N/A |
| TCR-2026-0091 | 25 Jul 2026 | Logbook LB-QC-014 (full, closed) | Static | Scanned PDF + controlled destruction | Manual scan | Every page verified; closed book | J. Nkemi (verifier: L. Duarte) | R. Gomez, 26 Jul 2026 | Destroyed | RD-2026-0033 (28 Jul 2026) |
The specimen shows all three common cases: a dynamic electronic archive certified by a validated process plus QA, a static paper copy retained alongside its original, and a static original destroyed after certification with the destruction authorization dated after the certification. Note the destruction date is after the certification date, never before.
Common inspection findings this register prevents
- An original was destroyed and no certification predates the destruction.
- A dynamic copy was certified on a visual comparison only, with no integrity or reprocess check.
- Certifications exist scattered with records but cannot be produced as a complete list on request.
- Register entries were backfilled after the fact rather than recorded contemporaneously.
How to adapt this register
- Set your Register ID scheme and align it with your document control numbering.
- Add a link or reference to the underlying certification statement and verification evidence for each row.
- If most of your copies are high-volume electronic batches, add a per-batch record-count column.
- Automate the checksum and reprocess-test evidence capture where your validated tools support it.
- Confirm the retention and destruction references against your records retention SOP before issue.