The strategic focus in life science technology investment is shifting from documents to data. Regulators are increasingly asking for data rather than documents and data-focused business processes, based on a single source of truth, are bringing efficiencies right across the organisation. Generis’ James Kelleher describes the implications of the transition away from structured document authoring.
Structured authoring was designed to be the future of document authoring – the ultimate efficiency in presenting the information. But the world is now moving away from documents as the medium of business information exchange. In the future, more and more information-based processes will be data-driven. This is great news, suggesting an end to issues with version control and a more traceable line back to the master source of intelligence.
But it does mean that structured document authoring, as a much-anticipated technology proposition, is already obsolete – before it really had a chance to get off the ground. For document management technologists and their customers, this is likely to feel very frustrating. Certainly, it will require a big strategic adjustment. But the upside is that companies now have a chance to leap-frog straight to a solution that is much fitter for purpose, transformational, pliable and sustainable in the long term.
Limitations of Structured Document Authoring
The original concept of structured document authoring, which dates back to the 1990s, is based on building routine documents from reusable segments of content. However, this soon comes up against practical limitations. If the approved, reusable content assets are entire paragraphs or sentences, typically these will need to be tweaked for each use case, for instance. With each edit, a new version of that content is created, with implications for change management.
In the meantime, the focus of Regulators and of recommended business practice more generally, has shifted towards live data as the primary source of truth, and as a means of transforming processes. This move away from document-based submissions and reporting further erodes the business case for structured document authoring.
Although regulated documents as official records of a product won’t disappear overnight, their ’Best Before’ date is drawing ever nearer. During the latter stages of the transition to ISO IDMP compliance in the EU, for instance, published documents will be phased out in favour of rolling data-based submissions: data that regulators can choose to analyse in their own way. Ultimately, data-based information exchange will become the preferred norm for regulatory submissions, PSMF (safety master) files and APQR (annual product quality review) reports. In fact, PV case file submissions in Europe are already submitted in data form.