What If Your Audit Logs Could Talk

Since the 1990s, when the European Union introduced its first comprehensive regulatory framework for medical devices, the European Directive on medical devices was introduced, and especially today with the new EU MDR/IVDR regulations, the volume and complexity of documentation required for regulatory submissions and ongoing compliance have increased dramatically. Manufacturers are now tasked with compiling extensive and continually evolving datasets into multiple, overlapping reports to meet stringent audit and review processes. 

A recent position paper by MedTech Europe highlights that the current PDF-based process for technical documentation submissions is highly inefficient and burdensome for manufacturers. The digitalization of Technical Documentation suggests a transition to a harmonized, item-based content management approach. This would allow for more efficient version control, easier updates, and reduced duplication, ultimately streamlining submissions to Notified Bodies and Competent Authorities.

MedTech Europe emphasizes that adopting a standardized digital framework would alleviate compliance burdens, improve data review efficiency, and help ensure timely patient access to medical technologies. A harmonized content management framework that separates content (data) from its presentation (form) can reduce the practical and cost burdens of compliance, while significantly improving the efficiency of the review process.

The good news is such a framework already exists and has been steadily growing for over 15 years. The Darwin Information Typing Architecture (DITA), an OASIS open standard, has been successfully adopted across industries including manufacturing, software, and more. Many medical device manufacturers have begun using DITA, but they have yet to fully leverage its potential as an open standard for streamlining the entire submissions process.

In practice, adopting a Structured Content Authoring (SCA) approach within a DITA-based Component Content Management System (CCMS) drastically reduces manual effort and minimizes errors.

SCA in components provides the foundation for managing content generated during manufacturing, regulatory, quality, and clinical activities in life sciences. Unlike traditional document-based approaches where Word documents, PDFs and Excel files are locked away or redundantly recreated SCA breaks content into reusable, modular components. These components can be dynamically assembled, versioned, and reused across reports, dossiers, and submissions.

A competent CCMS can assign unique IDs to each of the components, create and manage versions of the components, and easily provide auditable reports as to what components at what version was used to generate which output. An excellent CCMS will also connect to eQMS and other external databases and repositories within the organization, utilize knowledge graphs to demonstrate the relationships between the objects and use AI to generate new content from the existing, or be queried using a chatbot to provide answers to any sort of question. Questions impact analyses of a new development, to verification and validation of R&D requirements all the way to answering and providing auditable reports to regulators.

This approach improves compliance and consistency, accelerates protocol and regulatory document creation, and supports simultaneous, distributed authoring across global teams. It transforms report building from a siloed task into a collaborative, efficient process.

50% Higher Documentation Efficiency 

Philips has seen a significant boost in documentation efficiency, year-over-year. By automating the content management workflow, Philips can create and translate instructions for use more efficiently, all while keeping the same number of tech writers and translation managers. 

30-50% Reduction in Content Development and Localization Costs 

For Horiba Medical, the impact of Tridion Docs was transformative. Translation spending dropped by 50%, primarily due to the elimination of localization DTP (Desktop Publishing) costs.

32% Topic Reuse After 5 Years 

Waters Corporation achieved significant time and cost savings by reusing up to 60% of their content and streamlining publication processes with Tridion Docs. This ensured both consistency and compliance in their highly regulated industry. In practice, Tridion Docs enables substantial content reuse, resulting in a 32% reuse rate of topics even after 5 years. This ongoing reuse minimizes rework, reduces copy/paste errors, and maintains consistency across all documentation. 

Watch the case study 

• Automation & Efficiency: Streamline your documentation process and reduce time-to-market. 
• Cost Savings: Lower translation and localization costs by eliminating manual processes. 
• Long-term Value: Ensure that content remains reusable and up-to-date, saving time and reducing errors. 

By eliminating content duplication, Tridion Docs improves accuracy across every content touchpoint. This removes the need for manual updates. Every edit within Tridion Docs is captured in a 100% reliable audit trail, traceability is built-in, and evidence is always ready for auditors. 

Tridion Docs is an end-to-end structured content solution with a single source of truth for technical documents.

Tridion Docs Genius introduces AI-powered discovery, enhancing search results with Hexahops™, a new navigation paradigm, and Trustable Chat. These features work together to help your teams and customers get their work done faster, with greater confidence and accuracy. 

• The Trustable Chat interface delivers clear, source-linked answers using retrieval-augmented generation (RAG), ensuring users can quickly find the information they need (AI supercharges the latest version of Tridion Docs). 
• Hexahops™ offers intelligent recommendations, surfacing related topics and guiding intent-based search to help users navigate vast content without frustration. 

• Double productivity in documentation processes: Reuse and templates mean authoring and review are up to 2× faster. Assemble audit dossiers on-demand with granular version control, cutting review cycles roughly in half. 
• Zero errors, full traceability: A single-sourced CCMS ensures no conflicting copies. Every revision is auto-logged, capturing “every edit and comment in a 100% reliable audit trail.” This eliminates manual checklists and assures regulators can immediately see what changed. 
• Slash compliance costs: Modular docs cut content creation and translation costs by 30–50%, virtually eliminating rework. Analytics on reused vs. challenged content highlight risk areas so you can address them proactively. Overall, risk and rework decrease as regulators spend less time chasing errors.

They’d say,

That’s the power of structured content authoring in Tridion Docs, Tridion Docs Genius and Trustable Chat. With built-in traceability, AI-assisted navigation, and a single source of truth, your audit logs become a proactive partner in compliance, not just a passive archive.

Your documentation doesn’t just speak to tell the story of what happened, it provides clear, real-time answers your auditors can trust. 

Ready to harness the AI capabilities of Tridion Docs and unlock the value in your documentation? Contact an RWS expert for a demo on how Tridion Docs, Tridion Docs Genius, and Trustable Chat can make your audit logs and your entire eQMS speak for themselves. 

Further reading 

• Tridion Docs Medical Devices Case Studies 
• Digitalisation of Technical Documentation 
• Brochure: Tridion Field Services