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PDF (Portable Document Format) from Adobe is an important format in the pharmaceutical industry for storing information. The reason is that regulatory authorities, such as FDA, require that information is delivered in this format, as a PDF documents, once generated, cannot be manipulated anymore. This also means that e.g. pagination, is independent from which printer is used. So, if one refers to a certain page in a PDF document, this is a unique reference, unlike in Word documents, where the pagination is dependent on printer settings. Other advantages of PDF is that PDF documents can be provided with electronic signatures and with so-called "sticky notes".
In many companies, we see that PDF documents are generated from Word documents in a semi-automated fashion, where the data from the Word documents come from one or more databases. This of course is far from optimal.
With the venue of XML-technology, there is a much faster and more convenient way of generating PDF documents for regulatory purposes: data are retrieved from a database and converted to XML in an application. The same application also loads an XSL-stylesheet (so called XSL-format), so that the XML (internal) file is automatically converted to a PDF document. Within the same application, it is then also possible to convert the XML to other formats, if desired (e.g. Word, HTML).
Examples :
Stylesheets : Presenting CDISC-ODM Clinical Study data (in XML) as PDF
Applications : Automatic generation of Analysis Certificates.
