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 996 Annex 5 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.
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
How to Use It
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.
WHO TRS 996 Annex 5 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.