"Data is the heart of the business, whereas documents are the “packaging” with the intent to create the context of the data in the associated processes"

In December 2020 Forrester published a report that strongly confirmed our thoughts, and the developments we see in our market(s): The Future Of Documents: A Look Beyond The Paradigm Of Paper And Into Opportunities For Innovation – Forrester 2020. Based upon this report, we’ve interviewed thought leaders about the future of documents. In this article, Manuela Bernhardt (MB), Business Unit Director for Technology Services at fme USA LLC, shares her opinion.

The Forrester report points out that, although the tools for creating documents have become friendlier, the way workers and organizations think about documents really hasn’t changed since the introduction of personal computers.

What does a real disruption of this way of thinking about documents look like to you?
MB: “The real concept and value of documents is still misunderstood in many situations, and while the requirements have fundamentally changed a lot of scenarios, many companies have not realized this and continue to spend effort on ineffective and inefficient ways for content production, distribution, and use.
A key consideration for the regulated industry is that companies or business units often do not have the autonomy to entirely reengineer their document approach, as regulatory agencies continue to have static requirements regarding form, content and structure of documents which are required for review and approval processes– some rethinking on higher level might be needed here to better support an industry-wide shift.”

According to Forrester, document authoring is ready for its moment of disruption, though information worker habits have yet to change because:

  • Friction between cloud-native documents and file storage tools remains.
  • The mental model of paper dominates the language of content management.
  • Static file types clog up processes and require content fracking.
  • Employee preferences are entrenched.

What do you see as the biggest hurdles to changing the way workers and businesses work with documents?
MB: “We certainly see the recently introduced tools supporting the adoption process. To reach a “tipping point” of adoption, Authors will need to see and experience the ease-of-use and productivity value before being ready to change their processes. Once applications are ready to demonstrate that, and be adopted for specific use cases, the path forward will have some additional clarity and authors will be receptive to change.
Another key hurdle as highlighted earlier, is the regulated nature of the Life Sciences industry with its surrounding compliance and regulation requirements; enabling change will require cooperation by regulatory bodies to fully enable business-level process shifts.”

Can you name any practical examples where the disruption is already taking place?
MB: “The product-labeling use case has seen some consideration at our Life Sciences clients, they already have been using early versions of Structured Content authoring for the management of package inserts and prescribing information. This allows them to take advantage of reusable sections and to be able to quickly adapt to changes demanded by regulatory agencies across global markets.”

The real concept and value of documents is still misunderstood in many situations, and while the requirements have fundamentally changed, many companies have not realized this and continue to spend effort on ineffective and inefficient ways for content production, distribution, and use

Structured data will surround content. Documents that include structured data must become the norm when they’re the input for automated processes, such as invoice processing. Document creators must take an outside-in approach and deliver documents in formats fit for purpose.

How can we motivate authors to take this outside-in approach i.e. change their behaviour. What’s in it for them?
MB: “Tools have to be designed in a way to propagate benefits of data-driven document authoring to the authors. Ease of use is a key factor, especially the effort of pulling all necessary data together, which has to be minimized and not become an obstacle to overcome for the authors. Integrations to pull data and combine information from multiple data sources can be a key factor there – this can be an area where AI can support by identifying and extracting the necessary information from any relevant sources. Based on the available data, benefits for authors should include easy searching, filtering, dynamically navigating and reporting for the authored documents. Besides the capabilities of the technology, there is also the impact of on-going platform enhancements and release schedules to consider. Before a process is embraced, it is imperative to have a supporting change management process in place to enable users to continue working at pace, given the potential for recurring system change.”

It is expected that robots will share the writing credits with humans. AI authorship will affect document authoring in the near future.

What developments do you expect to see in this context, and what do you already see happening today?
MB: “Typical areas in which AI can take the lead in authorship can for example be weather or traffic statements that are purely wrapping data bits into more readable formats for consumers.
Looking at Life Sciences processes as our core business areas, direct AI authorship is less of a topic from what we have seen with our clients. Areas where AI comes into play though can be the deconstructing and constructing of content pieces to and from components based on defined rule sets in the systems.”

We see the increasing need and urgency to find structured document solutions within different processes of our Life Sciences clients

In the future, documents will be more fluid, componentized, and structured to separate underlying information from its presentation. A strong metadata-first strategy must replace the folder as an organizing principle and become a foundation for automation and AI.

What is in your opinion the difference between ‘documents’ and ‘data’?
MB: “Data is the heart of the business, whereas documents are the “packaging” with the intent to create the context of the data in the associated processes and therefore to increase the value by adding meaning to the core data. Depending on the business context, this might be of more or less importance – whereas invoicing processes are for example “all about numbers”, other processes as for example in Clinical studies might require more of an interpretation to be presented alongside the core data. The challenge being to keep metadata at minimum, and not to over complicate – overall, the data has to stay maintainable.”

Which content platforms are already evolving in this direction?
MB: “As provider of business and technology services supporting the deployment of business applications to clients in the Life Sciences Industry – specifically in the Regulatory, Clinical and Quality area – we are in close touch with Content Management and Business Application platforms such as Veeva Vault, OpenText Documentum, Generis CARA. What we can see is that these platforms are providing great value in managing data or documents, but in many cases, they are not designed in a way to support data-first structured document authoring. These functionalities need to be brought in facilitated by integrating with specialty applications and tools that are designed for these use cases. The goal has to be to make this integration as seamless as possible for the end users which is a key area of focus for us and our clients.”

Which industries are leading the way regarding the future of documents?
MB: “We see the increasing need and urgency to find structured document solutions within different processes of our Life Sciences clients – whether in Medical Writing, in the creation of CTD Module 3 and Module 5 documents, or in the management of localized Labeling documents. These industries have not been the drivers in the past, but due to the increasing importance in working as effectively and efficiently as possible to stay competitive in the market we expect them to be drivers and leaders moving forward.”

Manuela Bernhardt

Business Unit Director for Technology Services at fme US, LLC

Manuela Bernhardt on LinkedIn

FME Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.

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