This is our in data integrity network seminar encountered a problem.In this article, we will reply in detail.This is a common problem, because with the right software, PDF is editable.But think about it, no documents or files in isolated environment, the situation is how to exist.Documents are placed in the system, and in the GxP environment, the system will be under strict control.For a visa to pull viewLinc monitoring system, GMP data in the database of viewLinc from beginning to end..pdf report presents data only, it promotes the examination and approval of data, whether in the form of paper, or will. PDF file import electronic signature system.In the controlled system, should never let the other people in the case of unattended edit the PDF electronic file.

However, if someone is trying to edit viewLinc report, will appear the following situations:

. First of all, the data on the PDF will no longer match viewLinc data in the database.Don't match between database and the PDF document as evidence of a change.

. Second, the PDF (graphics file) may be changed to show different temperature, but the PDF file metadata will show changes;This is the file is further evidence of tampering.

In the controlled system, the PDF report will be electronically sent directly to the electronic document management system, by its routing for signature.Transmission before or during the process of transmission have no chance of editing, once in signature system, document that can be protected, will not be changed.(it is important to note that only when the signature in the system, the document is valid.Once removed, it will fail.

Our system of paper to a common to analogy, such as real estate transactions.Such signature is signed in the presence of notary public, and impartial third party hold signature events, identification and physical sign copies of independent record.You may claim this paper records, it's easy to edit and forgery, but if you get a copy and made some changes, and then walked into the local land administration (in the United States, may be the property agency or tax audit bureau) and claimed that the edited files to confirm you are the owner of the real property owned by everyone else's, what will happen?They will not give you the house, because after editing the truthfulness of the documents did not input is used to protect paper file system.

Electronic documents and paper records is similar.If not controlled, they will lose its authenticity.Imagine that someone from his pocket and extract a USB. The PDF file, and try to claim that it is real GMP records (such as for batch release or for computer validation), rather than have been integrated into the file protection system, time-stamped controlled files.This is clearly ridiculous, but it also indicates that the document is the protection of the system to which they belong.

All electronic file format from the SOP (and work process of executing SOP) control system, to maintain the effectiveness.

.pdf one big advantage is that it than Excel, Word, or the. TXT file is more difficult to change, behind these documents not graphics files, but the data files, can be easily used for transmission of data source in the future.PDF metadata can contrast image viewer and more.

The WHO - TRS - 966 appendix 5
Good data and record management practice guidelines glossary definition:

Static record format.Static record format (such as paper or PDF document) is a kind of fixed format, allows users to record content rarely edit or not allowed to edit.For example, once the print or converted to static PDF, chromatographic records were unable to process or unable to a more detailed look at baseline.

inThe same documentThe back of the:

Review of the original record special risk management matters needing attention
When people choose rely solely on paper hard copy or PDF report of computerized system, and does not meet the regulatory requirements in the application of original records, data integrity, the risk may occur.Should review the original records, including electronic records.If inspectors examine only a hard copy or PDF format data subset, may not be able to detect risk and possible harm.

(right), in other words, the document review should include a cross check static records with another source of data, for example, the report generation system database.