Original Data and True Copies

Figure 15.B-6 Definition of true copy excerpted from the glossary of the WHO Guidance on good data and record management practices (TRS No. 996, Annex 5, 2016)

Figure 15.B-7 Comparison of terms used for copies and original data

To avoid mistaking them for the original documents, copies must be marked (authorised copy, verified copy) and signed and dated by the originator. In the past, companies were often required to use only blue pens for signatures or entries in order to be able to distinguish originals from copies. In the age of modern color copiers, this requirement has become obsolete and has no legal basis.

If copies consist of several pages, it is advisable to either permanently bind them together, e.g. with a rivet, and mark only the first page, or to label each page accordingly (page ... of ...).

Thermal paper is used less and less often and is unsuitable for storage because it is not document-proof. This must be taken into account if, for example, chart recorder printouts are produced on this type of paper. In this case, it is recommended to make a copy on normal paper. The copy and the original with the initials or signature must be attached to the documentation.

Small-format attachments (e.g., labels, weighing records) must be pasted and dated and signed off “over the edge” to protect them from loss, i.e., half of the writing on the pasted slip, the other half on the backing sheet.