How to Create Process Documentation

“I can't wait to curl up with a good SOP tonight.” Said no one, ever. But in pharma, SOPs can mean the difference between life and death. You want a shared truth that serves as the foundation for safe, efficient, and repeatable workflows. So here’s my advice (having helped companies such as Pfizer and GSK with their documentation) on how to craft your SOPs so your team follows them consistently and successfully: 1️⃣ Know Your Cast of Characters 🎭 • Analyze roles: From lab techs to QA managers, everyone's got a part to play • Understand each role's specific needs (A chemist and a compliance officer walk into a lab...) • Consider how different roles will access and use the SOP A one-size-fits-all approach fits no one well in the pharma world. 2️⃣ Keep It Simple, Scientist 📝 • Short sentences are your friends • Active voice is your superpower ("Add reagent," not "Reagent should be added by you, maybe, if you feel like it") • Consistent terms (Pick a word and stick to it. This isn't a thesaurus contest) Nobody wants to decode War and Peace while handling active ingredients. 3️⃣ Format for the Skimmers (i.e., Everyone) 👀 • Embrace white space (it's not wasted space, it's breathing room) • Clear headings are your roadmap • One step, one action (multitasking = multierrors) A well-formatted SOP is less likely to be used as an impromptu pillow. 4️⃣ Picture This: Understanding 🖼️ • Diagrams and flowcharts (Worth a thousand words, especially when those words are "complex procedural steps") • Visuals that clarify, not confuse (no abstract art, please) • Callouts for the "Don't mess this up" bits Sometimes, showing is better than telling (and retelling, and explaining again). 5️⃣ Sections That Make Sense 📋 • Clear, logical sections (Introduction, Prerequisites, Steps, Troubleshooting, "What Not To Do Unless You Want An Exciting Day") • Keep it relevant (Save your weekend plans for the water cooler) • Include only the must-knows A well-organized SOP is like a well-organized lab: Everything has its place, and you can find what you need without a search party. Because in pharma, SOPs aren't just documents. They're the guardrails keeping us from chaos, contamination, and some very awkward conversations with regulators.

In the past 10 years, I’ve reviewed 100s of design docs. Here’s how to write review-ready design docs in 3 simple steps. 1/ Start with a skeleton, write these: • Metadata (Title, authors, status, date, reviewers, approvers) • Context and background • Problem statement • Summary or tl;dr (Optional) • Proposed solution details with tradeoffs and selection rationale  • Other alternatives considered • Failure modes of the proposed solution • Open Questions • References (Optional) 2/ After the skeleton, fill in the content under these headings. -If there are sub-sections, add sub-headings.  -Provide examples and sample calculations. -Use bullet points and lists wherever applicable -Include architectural diagrams, graphs and tables. 3/ If the document is large, put a summary after the problem statement. Start with the skeleton, take it one step at a time, and before you know it, you are done! Remember, a good design doc: -helps understand design decisions and implementation details -helps in identifying potential issues and challenges early  -gives a clear understanding of the architecture -serves as a reference doc during the project While you write and review, make sure your work follows these guidelines. I know writing detailed docs doesn’t come naturally when you’re focused on problem solving. But it’s an essential skill you have to learn to level up. just follow a simple procedure, practice and you’ll get the hang of it. – P.S: Check out additional writing tips in the comments below ↓

Just reviewed your procedures, …and – well – they’re not good… ->they’re either too detailed, turning into a novel, or so vague they leave the reader scratching their head. The secret? Tailoring your procedures to your audience and hitting that "just right" level of detail. Here’s how I try to strike the balance… ->Write for the people executing the procedure. Are they experienced engineers, junior analysts, or cross-functional (HR, Accounting, etc.) teams? Use language and concepts they’ll understand. ->Avoid unnecessary theory or deep background and PLEASE assume a baseline of competence. Outline clear, actionable steps someone ->skilled in the art<- can follow without needing extra guidance. ->Include enough detail to prevent confusion or missteps, but not so much that your procedure becomes heavy to follow or maintain. ->Use concise, active language. Focus on tasks, tools, and outcomes. Every word should add clarity & value to execution. ->Have someone unfamiliar with the procedure try to execute it. If they ask for clarification, refine it. If they finish without questions, you’re close to “goldilocks.” When procedures are done right, they empower your team to act confidently and consistently. Start by writing a procedure to make a peanut butter and jelly sandwich, then have someone follow it and provide feedback. Iterate and improve. #ciso #dpo #MSP #compliance #procedures