Documentation Maintenance Strategies

Imagine you’re an FDA reviewer wading through a medical device submission filled with complex and inconsistent terminology. Terms like JWT, NPM Package, DHQ, PPTA aDHQ, MIP Pipeline, and DICOM Validation Module are scattered throughout—sometimes defined, often not. Each document seems to speak a different language, making your job exponentially harder. As submitters, we might not realize how much these inconsistencies can slow down the FDA review process. A well-maintained glossary can be a game-changer, but creating and maintaining one isn’t always easy. 🤔 Why do glossary issues occur? • Keeping a consistent glossary is challenging. • Defining terms can feel abstract or low priority. • It’s not always clear which terms need definitions. • Team members may add terms without others noticing. • Engineers might use terms differently than the FDA expects (e.g., using “Validation Dataset” instead of the FDA’s “Test Dataset”). • Unclear origins of definitions can lead to unintended changes. 🛠️ Effective strategies to overcome these challenges: • Early team buy-in: Encourage your team to adopt a shared glossary from the start. Emphasize how it parallels good coding practices like DRY (Don’t Repeat Yourself) and KISS (Keep It Simple, Stupid). • Dedicated communication channels: Create a specific platform (like a Slack channel) for glossary discussions to keep everyone informed. • Regular terminology meetings: Align on terms and definitions as a team. Discuss FDA-preferred terminology relevant to your project. • Reference original sources: Link glossary terms to their original FDA guidances or standards to prevent unnecessary modifications. • Utilize glossary tools: Use platforms that facilitate glossary management. For example, Medtech OS automates glossary updates and team notifications, making maintenance more manageable. • Innovative solutions: We’re exploring AI-powered tools to flag documentation for missing definitions, duplicate terms, and more. 🌟 Benefits of a well-maintained glossary: • Streamlines FDA review: Clear and consistent terminology makes it easier for reviewers, potentially speeding up approval. • Enhances team collaboration: Everyone uses the same language, reducing misunderstandings. • Improves documentation quality: Minimizes errors and inconsistencies across documents. • Saves time: Reduces the need for revisions and clarifications, accelerating the submission process. A little extra effort in glossary management can go a long way in smoothing out the regulatory pathway. Have you encountered challenges with glossary management in your submissions? What strategies have you found effective? Share your experiences in the comments below! #MedicalDevices #FDA #AI

The legacy system documentation is a ticking time bomb. Hey y'all! Something's keeping me up at night: while everyone's drooling over the newest AI toys, millions of critical COBOL systems are running with documentation that's basically a hot mess of digital spaghetti. The documentation problem is REAL, folks. Most big companies have decades of system info scattered across random folders, personal drives, and (I'm not making this up) actual paper manuals locked in cabinets nobody can find keys for anymore. Why should we care? Because when your last COBOL expert retires next month, all that knowledge walks right out the door with them. And guess who's gonna be panicking when that mission-critical banking system crashes at 2 AM? Yep, you. Some facts that should make you sweat: • Most companies have ZERO actual documentation standards for legacy systems • Documentation is often older than most entry-level employees • New developers waste 60% of their time just trying to figure out how the darn system works • Critical knowledge exists only in the heads of people about to retireThe solution isn't fancy or trendy, but it works: get your documentation organized, people!Smart companies are doing some basic stuff that actually works: 1. Create a standard folder structure for ALL legacy documentation 2. Set up smart search capabilities (like Smart Folders) that can find any document across your entire system¹ 3. Use naming conventions that even new hires can understand 4. Make sure the right team members can access what they need 5. Create specific spaces for critical documents like system diagrams and emergency proceduresWill this problem get better or worse soon? My bet: it's gonna get much, much worse unless companies wake up and do something now. The good news? You don't need some expensive fancy solution. A well-organized folder system with decent search can turn your documentation chaos into something usable overnight. If you're running legacy systems without a documentation strategy, you're basically playing Russian roulette with your company's most important stuff. Don't be that person.

Building Knowledge-Centered Service Without Killing Momentum If every ticket becomes a writing project, your team burns out. But if no one documents anything, users suffer (and so do you). 1. Capture While Solving ↳ Use screen recordings, chat logs, or quick notes. ↳ You don’t need polished prose—just useful steps. 2. Start with the Repeats ↳ Prioritize common issues. ↳ If it happens more than twice a week, it deserves an article. 3. Make It a Team Metric ↳ Track KB contributions like ticket closes. ↳ Reward both. ↳ If you only praise speed, you’ll never build depth. 4. Use Templates ↳ Structure saves time. ↳ “Problem > Symptoms > Steps > Fix” beats freeform typing every time. 5. Assign Ownership, Not Just Tasks ↳ KBs without owners turn into graveyards. ↳ Assign authorship and review cycles. ↳ Maintenance is momentum. Knowledge-centered support isn’t about slowing down. It’s about scaling up—without burning out your top performers. Curious about the framework behind these habits? It’s called Knowledge-Centered Service (KCS) — a proven methodology for creating and evolving knowledge in real time. Learn more from the Consortium for Service Innovation. How do you balance documentation and speed in your ITSM teams? (Or is your KB still that mysterious link no one clicks?) 🔔 Follow Bob Roark for real-world ITSM strategy that helps your team go faster and smarter. ♻️ Repost if you’ve ever answered the same ticket 12 times and said, “I really should write this down.” ✶✶✶✶✶✶ Want to go deeper? The Grove Method for ITSM Excellence workbook outlines 7 core strategies I’ve used to drive performance, alignment, and stability in real-world ITSM operations. 📘 Get the eWorkbook (PDF): https://lnkd.in/g2kUi-nH 🖨️ Order the print edition on Amazon: https://lnkd.in/dDkgHGcE ✶✶✶✶✶✶