RECORDREFERENCE OUTLINE

True Copy Verification Record

Record for producing a copy that can replace the original, and recognising when it cannot. Establishes what the original consists of including its metadata, records the reproduction method per component, verifies before the original is disposed of, labels the copy, and marks convenience copies as uncontrolled with a review date. Maps to WHO TRS 1033 Annex 4 and the FDA data integrity and CGMP Q&A.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your access…

HOW TO FILL THIS IN
How to Make a True Copy and Verify It, step by step →
REGULATIONS MAPPED
WHO TRS 1033, Annex 4FDA DI & CGMP Q&A (2018)
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

A true copy reproduces the original including its meaning and, where applicable, its metadata, and is verified as complete and accurate before anything is done to the original. Get it wrong and you have destroyed an original and kept something that does not stand in its place. Whether a given reproduction method preserves the meaning of a particular record is your determination, not a property of the scanner.

What's Inside

✓Definition of what the original consists of, component by component, including metadata that carries meaning
✓Reproduction method recorded per component, with an explicit statement of what metadata survived the transfer
✓Verification checks against the original, with the result, the verifier and the date of verification
✓Labelling of the copy so a later reader knows it is a verified true copy and of what
✓A deliberate, recorded decision on the original’s fate rather than disposal by routine or by storage pressure
✓Convenience copies marked uncontrolled, with a review date so superseded versions do not circulate indefinitely
✓Approval by someone independent of the person who produced the copy, recorded on the same record

How to Use It

1Establish what the original consists of before copying anything — a scan of an electronic record drops exactly the metadata that made it trustworthy.
2Record the reproduction method per component; a single method statement hides the one component whose meaning did not survive.
3Reproduce content and meaning rather than appearance, and if metadata cannot be carried across, do not label the result a true copy.
4Verify before deciding the original’s fate, because destroying the original ahead of verification is destruction rather than transfer.
5Have verification performed by someone other than the person who made the copy, and record both names on the record.
6Mark convenience copies uncontrolled and give each a review date, or a superseded version gets worked from months later.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1What the Original Consists Of
2Reproduction Method
3Verification
4Labelling and Disposition of the Original
5Convenience Copies
REGULATORY CONTEXT

WHO TRS 1033 Annex 4 defines true copies and the verification that lets them stand in place of originals, and the FDA data integrity and CGMP questions-and-answers guidance (2018) addresses true copies of electronic records including their associated metadata. Neither tells you which metadata carries meaning for your record, which reproduction method preserves it, or when an original may be disposed of — those determinations sit with your organisation and its retention policy. The record structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
WHO TRS 1033, Annex 4FDA DI & CGMP Q&A (2018)
Browse the standards catalog →

WHERE NEXT

  1. FILL IT INHow to Make a True Copy and Verify It →The procedure this template records, one step at a time.
  2. ALL TEMPLATESBrowse all 122 templates →

A free account keeps what you save, remembers where you are across devices, and can send you the weekly regulatory briefing. Create a free account