Life sciences companies need to organize and manage critical regulated information about their products in smarter and more efficient ways.
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An organization’s compliance, safety and risk containment, speed to market, and overall market performance depend on product data being correct, complete, and easily repurposed for different requirements.
That’s why the industry has developed an appetite for structured authoring – the ability to be able to generate new documentation in an increasingly automated way from existing sets of data or ‘fragments’ of content that have already been approved.
However, by making the transition too quickly, many companies have come unstuck, resulting in projects achieving only a fraction of their intended scope, or the brakes being applied because an ambitious proof-of-concept has revealed the organization to be far from ready for the scale of change involved. Here we look at seven key steps that can make that journey more successful.
Start with popular office documents
Instead of taking a ‘big bang’ approach to the transition to structured content authoring, those managing regulated document creation should try to introduce the discipline of detailed document outlines, templates and tagging into their current document work, using the tools people already use every day. This will make a difference quickly and encourage people to start generating content in a more structured way.
Create strong templates
It seems incredible that busy professionals start more or less from scratch each time they create a common document, perhaps cutting and pasting existing headings or information from previous documents with at least some shared content. It would be far more efficient and reliable if users could start from a strong template which already contains the right structure, preferred headings and basic, correct content, leaving the content creator to focus on only the material that is new or different from previous iterations.
Explore the table of contents capabilities
Where a document’s table of contents is treated primarily as a tool for the reader, the emphasis is on keeping this short and easy to consume. But beyond Word’s high-level ‘outline’, a ‘view everything’ option reveals the potential to drill down to lower levels, with more detail about the sections and their contents. This can help to prompt document creators to be more consistent in their language and terminology, gently nudging them towards more standardised references which can be tagged and linked – the building blocks of structured authoring.
Analyse and consolidate content
Analyse content for deviations in expressions within documents - so that variants can be linked, or so that teams can work towards greater standardisation in their terminology and phrasing. All of this will enable specific content to be tagged more effectively and found more intuitively.
Eliminate dependency on word-based tagging
Once professionals have developed more of a natural discipline and consistency in their new document preparation and are regularly using master data to prepare new documents, they can start to move away from Word-based tags for important/frequently-used terms. They can transition comfortably to the kinds of smart structured-authoring tags that a content management system can analyse and use as the basis for smart automation in new document creation.
Transform content change management
When master data and structured authoring becomes the default way of working, the complexity and risk of introducing changes or updates to information ceases to be the risk and time-consuming occupation it once was. Now, there is a single, definitive place to update information – at source – with the confidence that any new documentation will automatically draw on that correct new content fragment.
Put structured content at the heart of all documentation
It will take up to two years to reach this objective, at which point, you should be in a position to harness master data for 100 per cent of all new document creation, across a wide range of use cases. Labelling, clinical study reports, global quality/SOP alignment, and CMC eCTD Module 3 pharmaceutical quality documentation are all excellent candidates for semi-automated production using pre-existing content fragments held in a master repository.
There is no doubt that structured content authoring and part-automated document generation is the future, however we need to set realistic expectations of how to get there. Laying the right groundwork – and giving professionals time to adjust to inputting information in a structured way – is the best way to ensure that companies can enable positive change.
About the author
Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.