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When can I destroy an original record?
I was asked to give my opinion on this recently. As the Pharmaceutical industry moves to more electronic processes but lab instruments still printing paper reports that they may not now require to maintain.
As far as reasonably practical, original GxP data records (whether they are paper or electronic) and system generated reports should be maintained unchanged in their original format. This makes it easier to show the provenance of the record during the data lifecycle.
During the lifetime of a data record there are many reasons why it may be necessary to copy and sometimes destroy (or delete) the original data record;
Original storage location has reached its capacity and old records are required to be removed.
Record is required to be included in multiple reports or files.
Original report print paper may not be robust enough to maintain the legibility of the original data during the required lifetime of the data record.
Computer applications (LIMS, ELN) which allow remote approval of data records may need a pdf version.
Original record requires to be archived but is not a significant GxP document and may be archived as a pdf.
Original record has been damaged or contaminated.
Legacy computer application is no longer supported and data must be stored in a third party application.
No matter what the reason for copying and destroying the original record there needs to be a written site procedure for copying original data and records. This procedure would require a person to verify and certify to confirm that the copy is exact and complete, that it preserves the entire content and meaning of the original record, including, in the case of electronic data, all essential metadata and original record format as appropriate (World Health Organisation, 2016).
For paper records this may be as simple as an ink-stamp and second person verification. While for electronic systems with auto-archiving functionalities it would require validation of the applications and verification for the activity.
So the answer to the query is; it is permissible to destroy original paper documents when there is a written procedure which explains in what circumstances an original record may be destroyed and which clearly explains the necessary steps to create and maintain a true copy of the original record.
