|Definition of a true copy according to WHO|
|A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including, in the case of electronic data, all essential metadata and the original record format as appropriate.|
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)
|Data type||Paper data||Electronic data types|
Initial capture of a document, data entry, or first printout. Primary data or original data is the first or originally captured data or information and any data subsequently required to fully reconstruct the performance of the GxP activity.
Collective term for duplicates, transferred data or multiple printouts."Unchecked" copies, i.e. copies that have not been checked, are only permitted in the GxP sector for information purposes, but not as a basis for evaluations or as work instructions.
Data transfers or multiple storage of the same record. Digitized paper documents are also often referred to as “electronic copies”.Uncontrolled and non-validated electronic copies are not permitted, as there is a risk of data loss, e.g. through accidental or intentional overwriting of existing data records
Also: exact copy, certified copy, one-to-one copyExact verified copy of a primary recording (certified copy); a true copy must always be labelled as such.
Copy created using a validated process that captures not only the pure numerical values but also the metadata, such as date/time stamps.The exact, verified copy of the original record can be static (e.g., as a PDF file) or dynamic (such as in an electronic record that the user can interact with).
|Verified copy||Paper document that is checked and issued to defined recipients according to the distribution list. A verified copy must always be identified as such (e.g. stamp, watermark, colored paper).||
Not defined.Access to electronic documents must be regulated via access authorisations. (In companies that have established electronic signatures, control or marking of copies by means of electronic signatures must be ensured).
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.
In the GMP Compliance Adviser you’ll find:
GMP in Practice
This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples.
These 8 chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more.