How to Optimize Your Documentation System

Is your GMP system collapsing under the weight of its own paperwork? If documentation is slowing you down more than it’s protecting patients, you’re not alone. It started with a deviation. Just a 5-minute delay in a mixing step. By the time it was closed, the team had created: 📄 47 pages of documentation 📚 9 cross-referenced SOPs 🧾 3 levels of review 🧠 A “lessons learned” log… for a low-impacting issue ✅ Every line: accurate. ✅ Every reviewer: diligent. ✅ Every link: cited. So why did the site fail its FDA inspection 3 months later? ⚠️ Because investigators couldn’t find the signal through the noise. ⸻ Over-documentation ≠ good documentation It feels safe to “cover all bases,” but it can backfire: • Reviewer fatigue • Delayed investigations • System inconsistencies • Missed critical info ⸻ 🌍 Expectations vary by region: 🇺🇸 FDA wants “adequate,” “contemporaneous,” and “complete” , not everything. 🇪🇺 EMA under Annex 1 stresses control + traceability, but favors lean. 🇬🇧 MHRA prioritizes clarity and risk-driven documentation. 🇯🇵 PMDA often prefers detailed redundancy, but still value-driven. 💡 No regulator asks for everything. They ask for what matters. ⸻ 📌 5 ways to escape the over-doc trap: 1️⃣ Use Risk-Based Thinking Apply ICH Q9 to scale based on impact. 2️⃣ Tier Documentation Group by: • Critical-to-Quality • Regulatory-Mandated • Operational Reference 3️⃣ Involve End-Users Early Ask: “What helps?” and “What slows us down?” 4️⃣ Digitize with Intent Don’t digitize chaos. Design smart, searchable systems. 5️⃣ Define Your Philosophy Set a documentation mission. Review it yearly. ⸻ 📣 Bottom line: From ICH Q10 to FDA’s quality maturity model—the signal is clear: ✨ Documentation should enable decisions, not bury them. — 🗣️ Your turn: Have you seen documentation slow down compliance? What helped you fix it? Let’s trade ideas. Because in GMP… Clarity is compliance. ♻️ Repost to increase awareness of your teams. #GMP #QualityCulture #RiskBasedApproach #GMPDocumentation #ComplianceLeadership #ICHQ10 #FDA #EMA #MHRA #PMDA #DigitalQMS #Biotech #PharmaManufacturing #RightFirstTime #QualityByDesign

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.

"Can I be brutally honest?" The pharma exec I was talking to over Zoom nodded. "Your writers are taking work home at night just to keep up. You're burning $12,500 monthly on unnecessary reviews. Plus, your teams are losing 250 hours each month to document revisions." Awkward silence. Then, something unexpected. A smile crept up the sides of his face, and he said, "I appreciate that kind of honesty." Backstory: He’d been burned by writing consultants before who didn’t dig deep enough and offered surface-level “grammar” workshops. "Go on," he said. So I told him about Mei, a senior writer in his organization who hadn't had dinner with her family in weeks because documents kept getting stuck in endless revision cycles. And I mentioned Raj, a reviewer who felt guilty about rushing through approvals because the backlog was overwhelming. The deeper we dug, the clearer it became:   - Writers desperately wanted to produce better documents but were drowning in a long review cycle and overwhelmed with contradictory comments - Reviewers felt pressured to approve quickly, without time for meaningful feedback   - Quality teams needed better tools but were stuck with outdated templates, poorly written SOPs, no style guide, etc.  "What's the solution?" he asked. I explained to him that writing and reviewing should be viewed as an ecosystem. When everyone has the same understanding of standards and goals, it’s much easier to produce effective documentation. And that critical thinking is the foundational piece of effective writing and reviewing. That means considering: - Who will be reading the document - What they’ll do with the document - & figuring out how to ensure that every word, sentence, and paragraph work to drive the desired conclusion. Then, we built a system that worked for everyone:   - Templates that actually guide, not just format   - Review processes with clear expectations   - Standards that both writers and reviewers understand  Three months later, Mei had dinner with her family on a Tuesday night for the first time in years. Raj started giving the kind of feedback that actually improved documents. The quality team became partners in the process, not the begrudging grammar police. Because when you build on critical thinking... When your writers have clear direction...   When your reviewers have a proper process...   When your team has frameworks that actually work for their use cases... That's when quality documentation becomes part of your culture, not a bottleneck in your pipeline.

Hate how boring and time-consuming documentation feels? Yeah, same. But here’s the thing: the more you avoid it, the more you hurt your future self and miss opportunities to showcase your skills properly. So if you want to make documentation less painful (and actually useful), here are 6 tips I use with my clients to make it faster, clearer, and more impactful: 1. Start with an overview What’s the purpose of your project? What problem did it solve? Just 3–4 lines to set the stage. Make it easy for anyone to understand why it matters. 2. Walk through your process Break down the steps: How did you collect the data? How did you clean, analyze, or model it? What tools or methods did you use? This shows how you think and how you solve real-world problems. 3. Add visuals A clean chart > a wall of text. Use graphs, screenshots, and diagrams to bring your work to life. (And bonus: you’ll understand it faster when you come back later.) 4. Show your problem-solving What roadblocks did you hit? How did you fix them? Don’t hide your struggles, highlight them. This is where your value really shines. 5. Summarize your results What did you find? Why does it matter? What’s next? Answer these three questions clearly and your audience will instantly get the impact of your work. 6.  Use a structure that makes sense Try this flow: Introduction → Objectives → Methods → Results → Conclusion → Future Work Simple. Clean. Effective. P.S: After every milestone, take 5 minutes to update your notes, screenshots, or results. Turn it into a habit. ➕ Follow Jaret André for more data job search, and portfolio tips 🔔 Hit the bell icon to get strategies that actually move the needle.

I cannot stress enough how critically important it is to take the time to build out systems that allow you to spend 0 time thinking about where your files are or how to access them. I have saved countless hours by taking more time upfront to set proper workflows and storage space for all my working and personal files. Some general principles to get you started: 1️⃣ Nothing is allowed to float - EVER. Don't let files float in your downloads folder or on your desktop. It will take you twice as long (if you are lucky) to find the file you need if things are allowed to float. Here is an example: Need to pull up a text editor to take notes during a meeting? The FIRST thing you are doing after that meeting is over is saving those notes (with a proper file name!) and storing it in the correct project location. Which brings me to point number 2: 2️⃣ Have a unique project location for every project. Projects of a similar type should all follow the same storage structure, but each project needs to have its own unique working space - no overlap. Example: Have two different projects for the same client? - each of those projects needs its own distinct working space to prevent misplacing items. 3️⃣ Have a specific system for each different file type you work with. Take and store meeting minutes the same way you do across all projects. Create, edit, and store deliverables the same way you do across all projects. Consistency is Key. 4️⃣ Last but not least - don't wait until the last minute to do these things - keep up with your notes and file saving as you work on these items. In the first example above where you pulled open a text editor to take meeting minutes - don't get in that situation in the first place. You should have your meeting minutes template opened and filled out with the meeting details already entered ahead of time. Work can be hard sometimes - no reason to make it harder on yourself - stay organized out there. Happy Sunday

Most SOPs fail before they even get written Why? Because they’re written for the boss, not the team. A lot of small business owners treat SOPs (Standard Operating Procedures) like a rulebook. Long. Rigid. Complicated. But real documentation isn’t about control. It’s about CLARITY. One client came to me after her VA kept missing steps in the onboarding process. She had a Google Doc. It was 7 pages long. No one used it. So we rebuilt it, together. ↳ We started by identifying just the three core workflows she needed help with most. ↳ Then we simplified. ↳ Created a step-by-step checklist for each task. ↳ Added visuals to show exactly how things should look. ↳ Recorded short Loom videos (each under 3 minutes) to walk her VA through the process. The result? ✅ Her VA stopped asking the same questions. ✅ Tasks were completed on time. ✅ She finally stopped waking up to Slack messages at 6 a.m. Here’s the truth most people miss: Good systems don’t live in your head…. They live where your team can find and use them. And when your team has access to simple, repeatable SOPs, they stop waiting, guessing, or spiraling. They just do the work. Struggling to get your team to actually USE the SOPs you’ve created? I created a free guide to help you build simple, streamlined SOPs your team will follow, without extra meetings, micromanagement, or overwhelm. Link is in the comment section below. This is exactly what I help small business owners do: Turn over complicated processes into clear, practical systems that actually get used So your team runs smoother, and you stay focused on growth. #systems #leadership #business #strategy #ProcessImprovement

🛠️ In my last post, I shared 7 reasons why data documentation is still so hard. Now let’s talk solutions: Here’s how leading data teams are solving each challenge today: 1. It’s no one’s core responsibility → Make documentation part of the workflow. Don’t allow dbt model PRs to merge without a model description. Treat documentation like tests—required for production. 2. Data is always changing → Use automated lineage and change detection. Get alerted when upstream tables or columns change. Use AI to auto-update or review the new docs. 3. Manual documentation doesn’t scale → Leverage AI to generate table and column descriptions. Start with smart defaults based on naming patterns and SQL logic. Let humans review and refine. 4. Your tools are fragmented → Adopt a centralized metadata platform. One place that connects your warehouse, dbt, BI tools, Airflow, ... so you can see the full picture. 5. Documentation is hard to find → Bring docs to where people work. Show table descriptions in query editors. Surface lineage in BI tools. Make metadata searchable in Slack. Metadata platform can help bringing documentation to tools that users are already working with. For example, Select Star has chrome extensions, Slack apps, and MCP server, that will display the relevant information within the apps. 6. No feedback loop → Track usage and engagement. See which docs are viewed or ignored. See which data assets are being viewed. Let users comment or flag stale content. 7. Lack of ownership → Assign data owners by table, dashboard, or metric. Use metadata tools to operationalize the data stewardship. Notify owners to review/update docs, when questions get asked, when things go out of date. Good documentation is no longer about extra work. With AI and metadata automation, it can be integrated into how your team already works. This is exactly what we’re building at Select Star—drop me a message if you want a look. Anything I missed? Also happy to elaborate more on any of the points.

Every consultant I know wastes time repeating the same things. I did too—until I found a better way. Working with many clients means answering the same questions over and over: How do we set up this automation?   What’s the best way to pull this report?   How do we implement this playbook? I used to reply with long Loom videos or detailed emails. Clients often lost these emails or forgot the steps. They would ask again weeks later. Then I started using Tango. Now, when a client asks how to do something, I send them a Tango guide. It’s already made, visual, and easy to follow. Instead of spending hours reteaching, I use that time to solve bigger problems. Consultants don’t get paid to repeat instructions. We get paid for strategic thinking. The more time we save from repeating ourselves, the more value we create. If you’re a consultant spending hours documenting processes manually, you’re wasting time on work that doesn’t scale. Here’s how to stop the cycle: 1. Document Processes   Use tools like Tango to create guides. Make them easy to follow. 2. Send Guides   When clients ask, send them the guide. It saves you time. 3. Update Regularly   Keep your guides fresh. Update them as processes change. 4. Focus on Strategy   Use the time you save to think bigger. Solve complex problems. 5. Teach Others   Share your guides with your team. Help them learn and grow. "The more you document, the more you can strategize." Start today.   Your time is valuable, and so is your expertise. Be efficient.   Be impactful. #TangoPartner

I scanned 2.8 GB of QMS documents in a week. Then, shared this uncomfortable truth with the QA director: More documentation ≠ a better quality management system. Most companies drown in paperwork that doesn’t actually improve quality. Want to fix that? Start here: 1️⃣ Kill redundant SOPs. Do you really need three SOPs saying the same thing Nope. Review processes and cut the fluff. 2️⃣ Make SOPs usable. Stop writing mini-novels. Focus on clarity and actionability—less “legalese,” more “get it done.” 3️⃣ Use risk-based thinking. Not everything needs a procedure. Focus on the high-impact stuff that actually matters. 4️⃣ Streamline approvals. Empower the right people to finalize documents. Endless review cycles = wasted time. 5️⃣ Go digital. Why deal with stacks of paper when workflows can live in a streamlined system? Go for a lightweight eQMS and automate what you can. The goal isn’t more documents—it’s lean, effective processes that drive compliance AND improvement. QA people have a great opportunity here to be creative, which is quite underrated. What would you add?

Documentation isn't busywork for project managers It's your backup. In fast-paced projects, it's tempting to skip notes and recaps. You might think "we're meeting all the time for alignment, there's no need to write it down." But then: → "That's not what I remember..." → "Who approved this?" → "Why wasn't I looped in?" Without supportive documentation to re-engage appropriately, you could end up opening a risk that could derail things. Here's how effective PMs use documentation as a shield rather than a checkbox: ✅ Recap everything After meetings, decisions, or even quick side chats, send a brief summary. It doesn't have to be a transcript, just WHO, WHAT, and by WHEN. Action items that are regularly shared and tracked are your friend. ✅ Track approvals in writing Verbal agreements are nice. Email receipts are better. Aligning on a decision isn't done until it's documented. Tip: have a shared document that shows all made decisions for alignment. ✅ Version control like your project depends on it One source of truth. Clear ownership. No guessing which doc is "final." Tip: archive old versions in one place, so you can go back to them if needed. Good documentation may feel slow. But slow is smooth, and smooth is fast. Especially when you need to cover your back when things speed up. PS: what's one habit you use to make documentation easier (and useful)? 🤙