Horiba’s playbook for regulated documentation that stays audit-ready

What does it take to keep documentation compliant across 27 languages, more than 900 documents per year, and a regulatory landscape that is continuously tightening? In this conversation with RWS Solutions Architect and Strategist Dipo Ajose-Coker, Agnès Massonneau and Anne-Marie Criado from Horiba share how RWS Tridion Docs helped their team stay audit-ready, cut translation spend by 80%, and build a content foundation they believe is already prepared for the next wave of AI-assisted documentation.

Regulated documentation that holds up under change

Customer	Horiba - in vitro diagnostics and laboratory instrumentation
Participants	Agnès Massonneau and Anne-Marie Criado, Technical Documentation Specialists
Scale	5–6 technical writers, 27 languages, 333 analyzer documents + 500 reagent documents + 100 technical notes per year
Compliance context	IVDR, FDA, MDSAP, ISO 13485, ISO 9001, ISO 14001
Starting point	A desktop-based help authoring tool (HAT) with no structured content reuse mechanisms
Solution	RWS Tridion Docs with structured authoring, Publication Manager, variables and conditions
Outcomes	80% reduction in translation spend, 80–99% topic reuse rate, 5/5 improvements in compliance, content quality, and productivity

Executive summary

Challenges	Maintaining consistent regulatory wording across hundreds of documents in 27 languages. Desktop-based software, workflows with no reuse model, compounding compliance and translation risk.
Solution	Structured authoring in RWS Tridion Docs. Single-source content reuse with variables and conditions. Publication Manager as the operational hub for managing all output variants.
Results	80% reduction in translation spend. Up to 99% topic reuse. Full 5/5 improvement ratings across compliance, content consistency, reuse, and documentation productivity.
Next steps	Adopting Draft Space and Review Space for reviewer participation. AI-assisted writing and content transformation for non-English contributors and SME inputs.

When you build precision instruments for regulated medical environments, by legislation and authorities, the documentation supporting these instruments is not a byproduct of a back-office function. It is process, it becomes part of the product itself. Horiba designs and manufactures high-precision measurement and analysis systems, including in vitro diagnostics instruments used in clinical laboratories worldwide. The documentation that supports those instruments must meet the standards of every market Horiba sells into. That means satisfying IVDR, FDA, MDSAP, ISO 13485, and several other frameworks simultaneously, across products, variants, and 27 languages. 

Agnès Massonneau and Anne-Marie Criado navigate that reality every day. Both came to technical communication from biology, and both landed in the role by chance. Agnès was hired partly because she had written scientific articles. Anne-Marie was trained by Agnès after joining from another department. Neither had formal technical writing training. What they brought was something often more valuable: a scientific instinct to identify problems and fix them, combined with an organizational culture that rewards working smarter rather than harder. 

"People who are a bit lazy are more creative," Agnès says, and she makes a serious point. That instinct for automation, the drive to eliminate repetitive manual work, is what separates documentation teams that scale from those that scramble. 

Their team of five to six writers manages more than 900 documents per year. The portfolio spans user manuals, daily guides, safety information booklets, technical procedures, reagent leaflets, safety data sheets, declarations of conformity, and more. Every document goes to multiple audiences in multiple languages. The documentation must be up to date, consistent, and all changes traceable at any point in time.

Before RWS Tridion Docs, Horiba’s documentation team worked in a desktop-based authoring tool. The tool used to be the industry standard for technical authoring, and it did the job for a while. But a desktop-based authoring tool does not offer structured content reuse in the sense that matters for regulated documentation management: the ability to write something once, control its use across multiple documents, and update it everywhere immediately when the content changes. 

In Horiba’s world, that gap had direct compliance consequences. Regulatory content, safety wording, and technical specifications appeared in multiple documents across multiple product families. Without a shared source model, changes had to be applied manually to each affected document. That created the conditions for drift: minor inconsistencies in phrasing, missed updates, and the ever-present risk that an auditor would spot two versions of what was supposed to be the same statement. 

The translation challenge compounded everything. Horiba publishes in 27 languages. Before Tridion Docs, a large portion of the translation budget was consumed not by translation itself but by the downstream handling of duplicated content. More text in, more cost out. Less reuse meant more repetition, and more repetition meant the cost multiplied across every language. 

The other challenge was structural. Their compliance obligations are not static. Standards evolve, and the pace of change is accelerating. The EU Data Act, new FDS norms, RFID labelling requirements, and AI-specific regulatory obligations are all arriving on compressed timelines. A documentation team that cannot propagate regulatory updates quickly and reliably is a team that creates risk for the business, whether an audit is scheduled.

The move to RWS Tridion Docs was a deliberate shift in operating model, not a tool upgrade. The team moved from a document-centric workflow to a topic-based, structured authoring environment where content is created once, governed centrally, and reused across all relevant publications. 

The transition required discipline. The team invested time in setting up workflows, defining commenting conventions for topic versioning, and establishing writing guidelines before scaling adoption. That upfront cost paid off. The discipline of the setup is now the foundation of their consistency. 

People outside the team are often surprised to learn they do not work in Microsoft Word.

That small detail tells the whole story. Structured content in a CCMS is not the obvious choice for a small team in a regulated environment. It is the right choice.

Publication Manager is the tool Horiba relies on the most. Variables and conditions allow the team to produce multiple publications from the same content base, targeting different product variants, regions, or output formats without duplicating the underlying source. 

The Conditions Manager gives them clear visibility into which conditions apply to which content blocks, making it easier to manage product-specific and market-specific variations without losing track of what is shared. This visibility matters in regulated documentation. When content is conditioned rather than copied, changes are traceable, controlled, and auditable.

The single most important workflow change is content reuse. When a regulatory requirement changes, the team updates the relevant shared topic once. That change propagates automatically to every publication that references it.

In practice, this means adding a compliance statement to every affected manual takes minutes, not days. The gain is not just time. It is quality assurance. Every document receives the identical approved wording. There is no version drift, no manually edited copy that was missed, and no inconsistency for an auditor to find.

Simple and disciplined: structure the content, govern the change, and automate the repeatable work. 

1. Structured content that enables controlled reuse: That structure is what makes reuse enforceable, not aspirational. 
2. Topic versioning and rules for comments: When auditors look for control, “we think we changed it” is not an acceptable answer. 
3. Variables and conditions for publication variants: to produce multiple publications from the same content base. This is where structured content starts paying rent. 
4. Publication Manager as the operational hub: manage deliverables and decide what gets included, updated, and released. 
5. Automation as a mindset, not a buzzword: The team culture is to optimize anything repetitive. They build macros and supporting tools, and they are unapologetic about it.

Audit confidence that shows up in real moments 

Agnès describes a specific audit where the outcomes of structured content became visible in real time. The auditor reviewed the documentation system, saw the topic versioning, examined the comparison tools, and checked the commenting approach the team uses to control change. The auditor left satisfied. 

"In audits, we are champions," Agnès says. That is not a boast. It is a description of what happens when controlled versioning, structured reuse, and a disciplined change process meet a regulated audit requirement. The evidence is in the system. The team does not have to assemble it at speed. 

80% reduction in translation spend, with more content and more languages 

Horiba has reduced translation costs by 80% since implementing Tridion Docs. The striking part is the context. That reduction was achieved while simultaneously increasing the number of languages they publish in and the volume of content they produce. Reuse at scale changed the economics fundamentally. 

Their topic reuse rate sits between 80% and 99%. When 80 to 99 out of every 100 content components are reused rather than recreated, the translation savings are structural, not marginal.

Outcome area	Before Tridion Docs	After Tridion Docs
Content reuse rate	Minimal - a desktop publishing tool (DPT) documentation model	80–99% topic reuse
Translation costs	High, compounded by duplicated content	80% reduction in translation costs
Regulatory update cycle	Manual, document by document	Update once, propagates automatically
Audit readiness	Evidence assembled on request	Versioning and comparison available in system
Publication variants	Separate document sets per variant	Single source, conditioned for each variant
Compliance confidence	Dependent on manual checking	Structured reuse ensures consistency across all documents

The team also rated their improvement in compliance, content quality, content reuse, and overall documentation productivity at 5 out of 5. These are self-assessments, but they reflect the same story the metrics tell: structured content changed the operating model, not just the output.

Faster regulatory updates with less drift 

When regulatory content changes, they can update shared content and apply it consistently across documentation. They described it as adding a phrase “in all documents” quickly, with significant time savings and a quality gain. 

Quality improvement through consistency 

This is the part teams often underestimate. Reuse is not only efficiency. It is risk control. They called out the benefit directly: reuse helps ensure they do not forget something or write the same idea differently in different places.

Structured content as the foundation for AI 

Agnès and Anne-Marie are measured about AI. They do not see it as a threat. They see it as an accelerator for specific kinds of work: drafting first versions, translating input from non-English speakers, and helping subject-matter experts contribute without needing to know DITA or structured authoring conventions. 

Their current constraint is translation. In medical devices, fully automated AI translation is not yet an accepted approach. Validation requirements and organizational confidence are not there yet. But they expect that to change, and when it does, they want their content to be ready. 

AI readiness grounded in structure, not hype 

"There is nothing better than structured documents for AI," Agnès says. The logic is straightforward. AI systems perform better when trained on organized, consistent, well-governed content. A team that has spent years building structured reusable topics has, in effect, already done much of the preparation work that AI adoption requires. 

Review Space and Draft Space (Collective Spaces) 

The team has not yet adopted Draft Space or Review Space. The reason is honest and familiar: they are always chasing deadlines, and carving out the setup time for a new workflow has not been possible. There is also a specific barrier with Draft Space: many potential contributors are not writing in English, and they do not know topic-based writing conventions. 

This is where they see AI playing a near-term role. An AI layer that could take a subject-matter expert’s input, in any language, and transform it into correctly formatted DITA-ready content before it enters the system would open reviewer and contributor participation significantly. That is the workflow they want to build.

The deeper lesson: invest in the foundation before you need to scale 

Both Agnès and Anne-Marie offer the same advice to peers starting out: understand how your writing choices affect translation before you write the first topic and invest the time in setting up the system correctly before you need it to perform under pressure. 

That advice is easy to ignore when teams are under immediate delivery pressure. It is harder to ignore when you consider that a documentation model built on copy-and-paste and manual updates cannot survive a serious regulatory change without significant rework. Structured content is the foundation. Build it once. Maintain it. Let it compound.

The Horiba story is not a story about a software implementation. It is a story about what happens when a small, disciplined team builds a content model that is designed to hold up under the conditions regulated industries face: constant regulatory change, multi-language publication, audit scrutiny, and the expectation to do more with the same headcount. 

The outcomes are not theoretical. An 80% reduction in translation costs. A reuse rate that runs to 99%. Documentation audit experiences that the team walk away from feeling like champions. These outcomes come from the combination of a structured content model, a governed change process, and a mindset that treats every repetitive manual task as something worth automating. 

And they come from a team of five to six writers. At scale, across 27 languages, under some of the most demanding regulatory frameworks in the world.

If your documentation process still depends on manual updates, duplicated content, and fragile coordination across languages and products, you are carrying compliance risk that does not scale. 

RWS Tridion Docs helps regulated documentation teams update once and reuse everywhere, stay audit-ready with controlled versioning and traceability, and build a structured content foundation that is ready for AI when the time is right. 

Map a structured content adoption path that fits your compliance requirements and your real operating constraints.