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Stop reinventing the wheel: why life sciences firms must be smarter about document production

Stop reinventing the wheel:  why life sciences firms must be smarter about document production


Stop reinventing the wheel: why life sciences firms must be smarter about document production
Last Updated: 18-Jun-2018
A lack of structured authoring in life sciences has limited companies’ scope to infuse regulatory processes with efficiency. But there’s scope to change that now, says AMPLEXOR’s Romuald Braun. In engineering-based industries, used of structured authoring – routinely populating documents with approved information components - is second nature. By contrast, life sciences has muddled through with simple office-style content tools for generating routine operational and regulatory documents.

This has meant that teams have had to start from scratch each time a new or updated document is needed – finding the right data all over again, and assembling it as required. As well as being laborious, this approach is error prone. But it has been hard to address these practical constraints before now, due to departmental information silos and variances in content formats and practice.

New automation options

Today, however, there are solutions that promote the concept of a single, master data and content repository, inspiring greater data hygiene and discipline.

The foundation for progress is strong, complete and reliable product master data, expressed in a standard way. Once the right data, in a consistent format, is easy to find and extract, it can be readily repurposed to support any number of use cases. Tight integration between systems and the core data source will be important so that information does not have to be re-entered, while providing users with a familiar input experience will help maximise adoption. Once companies have identified and finessed some approved master data combinations which can be used repeatedly in different content scenarios, they can start to automate the compilation of some of their more routine documents.

What to aim for

Given that the transition to advanced structured authoring could take a long time, a pragmatic way forward is to plan the transformation across a few distinct stages, as follows:

1. Transform routine monolithic documents into ‘smart’ documents. Replace some of the data items and values with intelligent tags, linked to master data so when information needs to be updated, this only needs to happen once - at source.

2. Use the table of contents to structure the outline of documents. Combined with tagging, this will result in content fragments that can be pulled into other documents, at speed.

3. Break down those content fragments further so they can be used in more documents. Aim to get down to the level of names of medicinal products, for example. These should be expressed in a standard way, even a consistent word order – eg ‘Aspirin, 100mg tablets’ every time, and not variations such as ‘Tablets, 100mg, Aspirin’. Look to create templates for these content fragments to aid this process, and to make re-use straightforward.

4. Continue this exercise until the company has arrived at the level of granularity it needs – e.g. for high-volume use in CMC, labelling and forms which feature lots of inherent structure, so lending themselves to maximum automation.

There is much to gain from all of this. Exploiting structured authoring based on approved master content will accelerate submissions for new products or entry into additional markets, and improve ongoing compliance. Other important benefits include operational cost savings, freeing up professionals’ valuable time and allowing companies to think laterally about additional market opportunities which now begin to look more viable economically.

About the author: Romuald Braun is VP of Strategy for Life Sciences at AMPLEXOR.