Regulatory Change Management Cycles in a DITA Environment

For companies operating in heavily regulated industries, connecting people to the right information at the right moment plays a central role in both their value propositions to the market and their compliance stance with regulators.

A key challenge for these organizations is that regulatory changes are a constant feature of the environments they operate in and the volume of these regulatory change updates has grown extensively in recent years.

The manuals, guidance and policies that organizations use to implement regulations and standards are increasing in complexity and size to ensure compliance. They require constant updates to reflect the most recent regulatory changes. A change in any one area can have a domino impact across a firm’s processes and procedures.

At the heart of many modern-day initiatives to tackle regulatory change management is a CCMS – Component Content Management System. A commonly used open standard with CCMS technologies is DITA. DITA provides a way to manage your content like an asset that can be easily reused and repurposed. This flexibility introduces new complexity for how to model changes over time.

At the heart of many modern-day initiatives to tackle regulatory change management is a CCMS – Component Content Management System.

What is DITA?

The Darwin Information Typing Architecture or Document Information Typing Architecture (DITA) is an open data standard that arranges content as components or topics and utilizes maps to give order to a collection of topics. Many CCMSs support DITA and it offers numerous benefits for the management of digital document-centric content including the following:

The ability to manage content as fragments

Because DITA provides a mode for thinking of large documents as collections of smaller components, it encourages document authors to manage content at a more granular level than previous generation Document Management Systems. In the case of regulatory/policy content, this granular level is typically the section/clause level. In other words, each section or clause becomes a DITA topic.

Content reuse

DITA topics can be repurposed so authors can write something once and use it many times.

Localization

If factored in from the beginning, DITA can streamline content localization.

Multi-channel publishing

A DITA component content management system (CCMS) manages content at a granular level and leverages DITA content’s re-use strategies to utilize one single source across different kinds of outputs.

These are just some aspects of DITA that make it a good fit for many regulatory change management use cases. However, DITA on its own has two central drawbacks.

XML markup is not for everyone

Firstly, writing in XML is complex for many subject matter experts more familiar with WYSIWYG (what you see is what you get) word processing environments like Microsoft Word. XML tagging allows the content to be enriched but it can be cumbersome, error prone and involve the use of unfamiliar tools.

Time and time again, we have seen that content changing over time is consistently an issue for a large number of DITA users across a variety of heavily regulated industries.

DITA does not address the pain points of regulatory change management

The component-based nature of DITA facilitates fine-grained version compare but there is a lot more to regulatory change management than just version compare. 

At Propylon, we work with governments, legislatures, legal publishers, and companies operating in heavily regulated industries. Time and time again, we have seen that content changing over time is consistently an issue for a large number of DITA users across a variety of heavily regulated industries.

In audit and accounting for example, a change to a FASB standard could introduce change across an array of documentation including audit manuals and guidance. Changes range from simple updates with an existing structure to wide-ranging updates in which new and amended content lives alongside old content that has been re-arranged or re-numbered in ways that make change tracking a lot more complicated.

In heavily regulated industries ranging from auditing/accounting to automotive to construction, we consistently see the same set of challenges. Dense interlinkages form between internal content (such as policy manuals, checklists, procedures, etc.,) and external content (industry standards, regulator guidance, regulations, legislation). 

When a change occurs in the external material, it is necessary to get an overview of the impact of the changes which involves tracing the relationships between internal and external material in a very fine-grained and meticulous way. 

DITA, for all its many benefits, says nothing about how to do this.

Minimize complexity

The temporal nature of Propylon’s CCMS platform is what enables our technology solutions to streamline regulatory change management processes. The platform records, manages and classifies changes to content as they occur over time. TimeArc features such as permanent point-in-time links and point-in-time views greatly increase the value proposition of DITA in regulatory change management environments.

On the surface, users work in familiar Microsoft Word-based WYSIWYG environments to keep on top of updates, pinpoint impacts of regulatory change in their existing material exactly and keep a full audit trail of the entire regulatory stance footprint – both internal and external content.

Meanwhile behind the scenes, the platform handles all the complexity of DITA XML data management, allowing users to easily find and re-use content blocks, all without leaving Microsoft Word.

While DITA offers numerous benefits for technical content management and publishing, where change is constant and complexity abounds, a CCMS that adds time as a fundamental pillar into the DITA model, is invaluable.