Why Annex/Part 11
There is much chatter on LinkedIn and within the Pharma Community about the revisions to Annex 11, which will automatically also become a harmonized worldwide PIC/s Guidance following the final revisions. Regardless of what you think about the content of the newly proposed regulation, in this blog I would like to address the “why” behind the need for specific regulation for GXP data collected/reviewed/etc. within electronic systems. Shouldn’t the EU GMP chapter 4 (Documentation) or FDA’s GCP found in the 320’s be sufficient to provide assurance of product quality and patient safety? Why do we need extra regulations that are so specific…?
My favorite quotes for defending any regulation (at least in the US) are found the “preambles” published within the Federal Register – an incredibly boring but yet still somehow interesting ‘magazine’. Random side note: do kids these days even know what a ‘magazine’ looks like? One of my all-time-favs is the Part 11 Preamble, published in 1997 (notably the same year that DVDs launched in the USA, remember those??). So, without further ado, enjoy the read:
Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997
“Absent effective controls, it is very easy to falsify electronic records to render them indistinguishable from original, true records. The traditional paper record, in comparison, is generally a durable unitized representation that is fixed in time and space. Information is recorded directly in a manner that does not require an intermediate means of interpretation. When an incorrect entry is made, the customary method of correcting FDA related records is to cross out the original entry in a manner that does not obscure the prior data. Although paper records may be falsified, it is relatively difficult (in comparison to falsification of electronic records) to do so in a nondetectable manner. In the case of paper records that have been falsified, a body of evidence exists that can help prove that the records had been changed; comparable methods to detect falsification of electronic records have yet to be fully developed.”
