True Copies in GMP: Scanning Paper Records to PDF Properly

A true copy in GMP is a copy of an original record that has been verified, by a dated signature or by a validated process, to contain the same information as the original, including its context and meaning. A scanned PDF becomes a true copy only after that verification, and only replaces the paper if your procedures allow it.

Scanning is how most sites move paper batch records, logbooks, instrument printouts and signed forms into an electronic archive. Done well, the PDF can serve as the record. Done badly, the original is destroyed and the copy is missing a page, a margin note or the colour of a correction. This guide covers the definitions, the conditions for replacing paper, and a practical scanning and verification routine. It is general information, not regulatory advice.

What counts as a true copy?

The main guidance documents use nearly the same definition. The MHRA's GXP Data Integrity Guidance and Definitions (revision 1, March 2018), section 6.11.2, defines a true copy as:

"A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original."

WHO's Guideline on data integrity (TRS 1033, Annex 4, 2021) uses the same wording for "certified true copy or true copy". In the United States, 21 CFR 211.180(d) allows required records to be kept "either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". The FDA's Data Integrity and Compliance With Drug CGMP questions and answers (December 2018), question 9, says electronic copies can be used as true copies "provided the copies preserve the content and meaning of the original record".

So the file format is not the test. A PDF can be a true copy; so can a photocopy. What matters is that the copy is complete and accurate and that someone, or a validated process, has confirmed it.

When can a scan replace the paper original?

MHRA section 6.11.2 allows it with a condition: "True copies of original records may be retained in place of the original record (e.g. scan of a paper record), if a documented system is in place to verify and record the integrity of the copy." It adds that organisations "should consider any risk associated with the destruction of original records". WHO section 11.15 says the same in shorter form: true copies may be retained in place of the original "where justified".

The PIC/S guidance PI 041-1 (1 July 2021), section 7.7, separates two purposes:

• Copies made for distribution, for example to send to a client: the original paper is kept by the record owner for the retention period.
• Copies made to aid document retention: "it may be possible to retain the copy in place of the original records".

PIC/S also expects a distribution list of issued true copies, checks that "true copies issued are identical (complete and accurate) to original records", and a quality agreement where true copies pass between companies.

Paper originals only

Scanning applies to records that started on paper. For electronic originals the guidance points the other way. PIC/S section 7.7 says a true copy of an electronic record "should be created by electronic means (electronic file copy), including all required metadata", and that "creating pdf versions of electronic data should be prohibited, where there is the potential for loss of metadata". FDA question 10 gives the example of an FT-IR spectrum: the file is dynamic and can be reprocessed, so a printout or static record "would not satisfy CGMP requirements to retain original records or true copies". Printing a chromatogram and scanning it does not make a true copy of the chromatography data.

Thermal paper and other fading prints

Balances, pH meters and some older instruments print on thermal paper, which fades. WHO section 10.3 says paper should not be temperature-sensitive or photosensitive, and "if this is not feasible or limited, then true or certified copies should be generated". PIC/S section 8.10 expects that for "printouts which are not permanent (e.g. thermal transfer paper) a verified ('true') copy should be retained". Copy these prints soon after they are made, while the text is still dark, and keep the copy with the batch or test record they belong to.

How to scan a paper record so the copy is complete

None of the guidance sets a scanning resolution or file format, so your procedure has to. Base the settings on a test with your smallest print and faintest handwriting, then fix them. Points that matter in practice:

1. Prepare the original. Remove staples carefully and unfold corners. Scan attached labels and notes in place, and scan again with them lifted if they cover text.
2. Capture every side. Scan reverse sides that carry anything at all, including signatures, page numbers or "intentionally blank" statements. Removing a blank-looking page can remove the only evidence that it was blank.
3. Use colour where colour carries meaning. Ink colour, coloured paper used for controlled forms, highlighter and red corrections can matter to a reviewer. Greyscale can lose them.
4. Keep the whole page. Margins hold initials, dates and notes. Do not crop to the printed area.
5. Avoid image "improvements" on the record copy. Despeckling, contrast boosting and automatic deskewing change the image. If your procedure allows them, they belong in the validated process, not in an ad hoc step.
6. Name and index the file so it can be found and tied to the original: record number, batch number and page count.

If your scans arrive as JPG or PNG images, for example from a document camera, JPG to PDF can combine them into one PDF in your browser. JPEG and PNG files are placed in the PDF as they are, without being re-compressed. By default each image is scaled down to fit an A4 page with a half-inch margin, so the page size in the PDF does not tell you the size of the original paper; note it in the index if it matters. Our guide on how to convert JPG to PDF covers the settings.

How to verify the copy

Verification is what turns a scan into a true copy. A typical manual check, done by someone who did not scan the record if your procedure asks for independence, covers:

• Page count: the PDF has the same number of pages, or sides, as the original.
• Order: pages are in sequence and none are duplicated.
• Legibility: every entry, signature, date and correction is readable at normal zoom.
• Completeness: margins, stamps, attachments and reverse-side content are present.
• Record of the check: who verified it, when, and against which original, using a dated signature or the electronic equivalent your procedure defines.

Once verified, protect the file. PIC/S asks inspectors to "check that scanned or saved records are protected to ensure data integrity". In practice that means storing it in a controlled repository with access control and backup, not in a personal folder.

Where OCR fits

A scanned PDF is a picture of text. OCR (optical character recognition) adds a searchable text layer so you can find words in it. That is useful for retrieval, but the recognised text is an interpretation and can contain errors, especially with handwriting. The page image is the copy; the text layer is not.

The OCR PDF tool keeps the scanned page images and draws the recognised words on top as invisible text. It also changes the PDF's title, subject and keywords to show that OCR was run. Because that alters the file, decide where OCR sits in your procedure: either run it before verification, so the verified file is the searchable one, or run it on a working copy. Our guide on making a PDF searchable with OCR explains the settings. Priya LifePDF is a general-purpose tool, not a validated GxP system, so its use in a true copy process needs the same assessment as any other software.

This article is general information, not regulatory advice. Whether scanned copies can replace originals at your site, and how they are verified, is decided by your quality system and QA team.