Regulated content, region by region
DitaExchange runs in six regulated sectors across four region clusters. The matrix below maps the primary regulatory framework that applies in each cell. Pick a row to read the detailed sector page.
Read the sector pages
The regulatory framework that applies in each sector and region
Buyers recognize their own framework before they recognize a product category. This is the map DitaExchange is built against.
| Sector | North America US · Canada | Western Europe EU institutions · FR · BE · NL · IT · ES · PT | DACH Germany · Austria · Switzerland | UK & Nordics UK · DK · NO · SE · FI |
|---|---|---|---|---|
| Life Sciences | FDA QMSR · 21 CFR Part 11 | EU GMP · eCTD · IDMP | BfArM · Swissmedic | MHRA · Nordic regulatory cooperation |
| Financial Services | SEC · FINRA · SOX | MiFID II · EMIR · DORA | BaFin · FINMA | FCA · PRA · Finanstilsynet |
| Aerospace & Defense | ITAR · MIL-STD · DFARS | EASA · EDA · EU Defense Fund | BAAINBw · armasuisse | UK MoD JSP · NATO STANAG |
| Government & Regulators | CNSC · Federal Register · Canada Gazette | EASA · EDA · EUR-Lex | BAnz · Bundesanzeiger | Lovdata · Retsinformation |
| Nuclear & Energy | CNSC · NRC · FERC | IAEA · Euratom · ENTSO-E | BNetzA · ENSI | ONR · Ofgem · SSM · STUK |
| Technical Documentation | ANSI Z535 · S1000D · ASD-STE100 | EN ISO 17100 · EN 82079-1 | VDI 2770 · tekom | ASD-STE100 · IEC 82079 |
Frameworks change on their own schedule, and rarely in step with each other. A sector page sets out what that means for the content itself: which documents fall in scope, what has to be provable, and where a structured component model removes work rather than adding it.
The six sectors DitaExchange serves
Each page covers the regulatory pressure specific to that sector, the content it applies to, and the customers already running it in production.
Life Sciences
Regulatory submissions, labeling and clinical documentation, where the answer needs to be ready before the regulator asks for it.
Financial Services
Disclosures, policy documents and controlled publishing, with governance enforced in the workflow rather than described in a process document.
Aerospace & Defense
Airworthiness rules, technical manuals and defense-procurement specifications, multi-variant publications where reuse is the entire point.
Government & Regulators
Rulemaking, statutory instruments, guidance and consolidated law, amended continuously and cited by everyone downstream.
Nuclear & Energy
Reactor manuals, plant safety cases and decommissioning records, where the audit trail is itself the deliverable.
Technical Documentation
Modular content for product portfolios, where each new variant draws from the validated pool so the work stays incremental instead of duplicated.
Frequently asked questions
Our sector is not one of the six. Does that rule us out?
Not automatically, but settle a different question first: does inconsistent content carry a regulatory, legal or financial cost in your organization? That is what the six sectors have in common, not their subject matter. If nothing downstream breaks when two documents disagree with each other, a component model is overhead, and the honest answer is that a CCMS is the wrong purchase.
Why are Government and regulators listed separately from nuclear and energy?
Because the two sit on opposite sides of the same rule. A regulator drafts, consolidates and publishes the rule itself. An operator reads that rule and has to prove its own documentation complies with it. Both are component-content problems, but the deliverables, the reviewer population and the publication cadence are not the same.
We operate across several regions. Does each framework mean a separate document set?
No, and avoiding that is where a component model earns its place in a multi-region estate. One approved component is written once and profiled per market, so two regional outputs share the wording they have in common and differ only where the frameworks differ. What gets maintained is the difference, not a full parallel copy per jurisdiction.
Which framework dates are moving in 2026?
FDA QMSR took effect on February 2, 2026, replacing 21 CFR Part 820 and aligning with ISO 13485:2016. EU AI Act Article 50, the content transparency provision, applies from August 2, 2026. Each of them changes what has to be provable about the content rather than what the content says.
Does the product change from one sector to another?
No. The same four products run in every sector: DxMigrationTool, Dx5, DxAuthor+ and DxChecker. What changes is configuration. The taxonomy in the SharePoint Term Store carries the sector's vocabulary, the DxChecker rule set encodes its terminology, date-format and required-metadata rules, and the publishing outputs match what that sector's regulator or customer expects to receive.
Which of these is your sector?
Bring the documents you actually have to maintain. We will walk through what a structured component model does to that workload, in your regulatory context rather than in general terms.
