7 incremental steps to multi-purpose structured content management
SummaryLife sciences organisations are gradually realising that if they could stop managing regulated product information as a series of monolithic documents created from scratch each time, they could transform everything from regulatory information and submissions management, to global/local labelling and quality & safety validation. But how do they get to that point? Romuald Braun of Amplexor advises on a gradual transformation.
- Author Company: AMPLEXOR
- Author Name: Romuald Braun
- Author Email: firstname.lastname@example.org
Life sciences organisations are gradually realising that if they could stop managing regulated product information as a series of monolithic documents created from scratch each time, they could transform everything from regulatory information and submissions management, to global/local labelling and quality & safety validation. But how do they get to that point? Romuald Braun of Amplexor advises on a gradual transformation.
To transform operational efficiency, life sciences organisations must find smarter ways to manage critical regulated information about their products. Their compliance, safety and risk containment, speed to market and overall market performance depend on product data being correct, complete and readily re-usable for numerous different purposes. This could serve document generation across the entire development, approval, distribution, consumption and updated-release lifecycle, globally.
It is in this context that the industry has developed a keen interest in structured authoring – the ability to generate new documentation in an increasingly automated way from ‘fragments’ of already-approved master content.
Yet some organisations have tried to make too big a transition too hastily, resulting in projects achieving only a fraction of their intended scope - or the brakes being applied. An alternative way, which is less radical and more inclusive, offers better results:
1. Start with Microsoft Word.
Look to introduce detailed document outlines, templates and tagging into 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.
Microsoft Word has a range of useful capabilities for structuring content, which are rarely exploited to their full potential. Examples include the document outline, or table of contents, which keeps titles, sections and subheadings in order - and linked, so that readers can skip to the parts they need.
2. Create standard templates.
Rather than let busy professionals reinvent the wheel each time they create a common document, establish a strong template which already contains the right structure, preferred headings and basic, correct content. This leaves the content creator to focus on only the material that is new or different from previous iterations.
3. Make more granular use of the table of contents.
Beneath Word’s high-level document ‘outline’, a ‘view everything’ option reveals the potential to drill down to lower levels with the table of content, with more detail about the sections and what’s in them. This prompts document creators to be more consistent in their language and terminology, choosing standardised references which can be tagged and linked – the building blocks of structured authoring.
4. Content analysis & consolidation.
Here the emphasis is on analysing 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 and found more effectively.
5. Remove reliance on Word-based tagging.
Once there is more of a natural discipline and consistency in new document preparation, and teams 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.
6. Transforming content change management.
Once use of 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 burden 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 the right content fragments.
Although those with authority will still need a quality control process, as well as special workflow rules to ensure updates are applied only where needed, the scope for transforming change control and increasing document quality is vast.
7. Structured content authoring accounts is the means for all document creation.
It could take up to two years to get to this point. By now, life sciences companies 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.
Conclusion: setting expectations
It is only by laying the right groundwork – and giving professionals time to adjust to inputting information in a structured way – that companies can hope to effect lasting and wide-reaching change for the better. A sure and steady approach to transformation can pay dividends.
About the author
Romuald Braun is VP of Strategy for Life Sciences at AMPLEXOR. He holds a Master’s degree in Drug Regulatory Affairs and an Engineers’ diploma in Data Technology, and has spent the last 26 years working in compliance, document management and content management related roles in this industry - in client-based as well as consulting and project management roles.
Web site: www.amplexor.com
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