Within the pharmaceutical branch there exist numerous important documents with high demands on document quality which typically must be archived for extended periods of time.
Document-oriented GxP applications have for years been recommending PDF as the optimal document format for archiving and document exchange.
Regulatory guidelines generally require at least PDF 1.4, and since 2011 there is a recommendation for PDF 1.7, now published as ISO Standard 32000-1, which is the PDF format that Adobe handed over to the ISO.
PDF/A is the ISO standard for the long-term archiving of documents and has established itself in many pharmaceutical companies as best practice. Part 1 of the PDF/A standard (PDF/A-1) is based on PDF 1.4 and Part 2 (PDF/A-2) on PDF 1.7, so it is only a small step to go from PDF to PDF/A in most cases. Through use of PDF/A in the pharmaceutical branch, an extremely high technical quality of documents can be ensured and PDF/A guarantees the unambiguous reproduction of documents for long-term archiving.
Digital documents, for example packaging inserts, can be securely archived as PDF/A files.
The German Society for Good Research Practice (Deutsche Gesellschaft für Gute Forschungspraxis e.V.) has created a guideline for digitizing paper documents – “Digitization of Documents in a GxP-Regulated Environment” – which provides an excellent overview with concrete recommendations.
Author: Thomas Zellmann, LuraTech Europe GmbH.