Reducing Manual Intervention in Processes

The quest for quality often leads software organizations down a paradoxical path: adding more manual checks and approvals that actually make quality worse, not better. Release processes that require manual QA signoff, security review, or executive approval might feel safer, but they create long, unpredictable feedback cycles that hide problems and increase risk. Consider what happens when teams batch up multiple changes for a big release requiring manual review. Engineers context-switch to new tasks while waiting for approval. When issues are found, the original context is lost and debugging becomes complex. Meanwhile, more code is being built on potentially problematic foundations. The cycle repeats, creating a growing backlog of changes waiting for review. This pattern appears in many forms. Manual QA phases that take days or weeks. Change review boards that meet monthly. Pre-release checklists that grow ever longer. While each addition to the process aims to improve quality, the cumulative effect is often the opposite: larger, riskier deployments that are harder to troubleshoot when things go wrong. The most effective teams recognize that rapid, automated feedback is far more valuable than manual process gates. They invest in automated testing, continuous integration, and tooling that catches issues early. They deploy small changes frequently rather than batching them up. When manual reviews are needed, they happen continuously rather than becoming bottlenecks. So, remember: - Large batches of changes increase risk, not safety - Manual approvals create queues that hide problems - Long feedback cycles make debugging more difficult - Automated checks scale better than manual processes - Frequent small deployments tend to be lower risk than infrequent large ones The path to better quality is enabling faster feedback through automation and smaller batch sizes—it's not adding more manual processes. Truly embracing quality at scale requires letting go of the illusion of control that manual processes provide.

Too often, cell therapy developers choose 𝗼𝗽𝗲𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 for flexibility, only to face the consequences later. While open workflows may seem practical at first, they carry 𝘀𝗶𝗴𝗻𝗶𝗳𝗰𝗮𝗻𝘁 𝗵𝗶𝗱𝗱𝗲𝗻 𝗰𝗼𝘀𝘁𝘀. The FDA emphasizes closed systems wherever feasible to reduce contamination risk. Today, I break down the cost, complexity, and scale limitations inherent to open processes. 𝗜𝗻𝗳𝗿𝗮𝘀𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲 𝗮𝗻𝗱 𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗖𝗼𝘀𝘁 Open processes require work in Grade A spaces (e.g., BSC) within a Grade B background, which cost 𝟯𝟬 - 𝟰𝟬% 𝗺𝗼𝗿𝗲 𝗽𝗲𝗿 𝘀𝗾𝗳𝘁 than the Grade C or D cleanrooms used for closed systems and require more advanced HVAC, gowning, and environmental monitoring, further driving up operating expenses. 𝗖𝗼𝗻𝘁𝗮𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗕𝗮𝘁𝗰𝗵 𝗙𝗮𝗶𝗹𝘂𝗿𝗲 𝗥𝗶𝘀𝗸 While contamination rates for CAR-T are not widely reported, data from 𝗼𝗽𝗲𝗻 autologous stem cell workflows show rates from 𝟬.𝟲 - 𝟭𝟯%, underscoring the risk of manual, open processing. When each batch represents a patient, a single contamination event can cost hundreds of thousands of dollars in product loss, delayed treatment, and regulatory impacts. Closed systems using sterile, single-use fluid paths eliminate environmental exposure, resulting in 𝗻𝗲𝗮𝗿-𝘇𝗲𝗿𝗼 𝗰𝗼𝗻𝘁𝗮𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 and greater process reliability. 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝗖𝗼𝗺𝗽𝗹𝗲𝘅𝗶𝘁𝘆 Open processes require 𝘀𝗲𝗽𝗮𝗿𝗮𝘁𝗲 𝘃𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 for each instrument and manual step, including IQ/OQ/PQ, cleaning validation, aseptic simulations, and SOPs, all of which add to QA workload and documentation. Closed systems are often validated as an integrated unit, simplifying GMP onboarding. 𝗧𝗲𝗰𝗵 𝗧𝗿𝗮𝗻𝘀𝗳𝗲𝗿 𝗮𝗻𝗱 𝗥𝗲𝗽𝗿𝗼𝗱𝘂𝗰𝗶𝗯𝗶𝗹𝗶𝘁𝘆 Open processes almost always depend on manual interventions, making tech transfer across sites or CDMOs difficult. Operator variability drives inconsistencies, increasing the 𝗿𝗶𝘀𝗸 𝗼𝗳 𝗱𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻𝘀, 𝗯𝗮𝘁𝗰𝗵 𝗳𝗮𝗶𝗹𝘂𝗿𝗲𝘀, 𝗮𝗻𝗱 𝗲𝘅𝘁𝗲𝗻𝗱𝗲𝗱 𝗯𝗿𝗶𝗱𝗴𝗶𝗻𝗴 𝘀𝘁𝘂𝗱𝗶𝗲𝘀. Closed systems offer standardized, reproducible workflows that simplify transfer. 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗦𝗰𝗮𝗹𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Open processes scale inefficiently. Each batch adds to demand on cleanroom space, scheduling, and QA, creating bottlenecks as volume grows. Operator multitasking is limited by the need to maintain sterility and documentation during parallel open steps. Closed systems reduce manual handling and environmental dependence, enabling parallel batch processing with less staff and space, which is key for early trials and distributed models. 𝗡𝗼𝘁 𝗮𝗹𝗹 𝗚𝗠𝗣-𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 𝗮𝗿𝗲 𝗚𝗠𝗣-𝗿𝗲𝗮𝗱𝘆, and the earlier you think about that, the better. Whether you're still optimizing your preclinical workflow or preparing for IND, I’m happy to share my perspective on how to simplify, close, or future-proof your process.

𝗧𝗵𝗲 𝗦𝗶𝗹𝗲𝗻𝘁 𝗚𝘂𝗮𝗿𝗱𝗶𝗮𝗻 𝗼𝗳 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗦𝘂𝗰𝗰𝗲𝘀𝘀—𝗥𝗲𝗶𝗻𝘃𝗲𝗻𝘁𝗶𝗻𝗴 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀 Business process controls have long been reactive. They were introduced to meet regulatory requirements after corporate failures. But this approach is outdated. Organizations must shift to a proactive strategy to counter internal and external risks. Controls should be embedded into process design from the start. 𝗥𝗲𝗱𝗲𝗳𝗶𝗻𝗶𝗻𝗴 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝗹 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀: 𝗔𝗜, 𝗥𝗣𝗔, 𝗮𝗻𝗱 𝗕𝗲𝘆𝗼𝗻𝗱 Technology is transforming business process controls. 𝗔𝗜-𝗗𝗿𝗶𝘃𝗲𝗻 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀: AI analyzes vast amounts of data in real time. It detects anomalies, predicts risks, and ensures compliance automatically. 𝗥𝗣𝗔 𝗶𝗻 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗔𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗼𝗻: RPA eliminates manual effort. It automates transaction monitoring, compliance validation, and repetitive tasks. 𝗣𝗿𝗲𝗱𝗶𝗰𝘁𝗶𝘃𝗲 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: AI and analytics help businesses spot risks before they materialize. This prevents costly errors and ensures smooth operations. 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆-𝗘𝗻𝗮𝗯𝗹𝗲𝗱 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝗹 𝗔𝘂𝗱𝗶𝘁: 𝗧𝗵𝗲 𝗡𝗲𝘅𝘁 𝗘𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻 Internal audits must evolve alongside business processes. Traditional manual audits are slow and inefficient. AI and automation enable real-time auditing and continuous monitoring. 𝗗𝗮𝘁𝗮 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝘀 & 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲: Auditors can now access structured and unstructured data. This allows deeper risk insights and better decision-making. 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗠𝗶𝗻𝗶𝗻𝗴: Digital footprints from transactions reveal inefficiencies. Auditors can track deviations and improve compliance. 𝗠𝗮𝗰𝗵𝗶𝗻𝗲 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗶𝗻 𝗔𝘂𝗱𝗶𝘁𝘀: AI-powered audits identify high-risk areas. They predict anomalies and suggest corrective actions before issues arise. 𝗞𝗲𝘆 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀 Organizations must implement various types of controls to prevent errors, detect anomalies, correct issues, guide compliance, ensure cybersecurity, and adhere to regulatory requirements. These include preventive, detective, corrective, directive, IT security, and regulatory compliance controls. 𝗪𝗵𝘆 𝗣𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝘀 𝗠𝗮𝘁𝘁𝗲𝗿 Switching from reactive to proactive business process controls brings significant advantages: • Error Reduction: Automation eliminates manual mistakes. • Efficiency Gains: AI and automation speed up workflows. • Risk Mitigation: Predictive analytics detect risks early. • Cost Savings: Fewer errors mean lower financial losses. • Better Decision-Making: Real-time insights help leaders act faster. • Regulatory Compliance: Continuous monitoring ensures adherence to evolving laws. 𝗧𝗵𝗲 𝗧𝗶𝗺𝗲 𝘁𝗼 𝗔𝗰𝘁 𝗶𝘀 𝗡𝗼𝘄 Modernizing business process controls ensures efficiency, resilience, and compliance. 

After leading workshops with over 50 SME leaders this year, I heard the same pain point again and again: "Digitalization sounds great, but where do we even start without getting overwhelmed?" That's exactly why we co-created the "Leitfaden Digitalisierung für KMU" with the University of St. Gallen—a practical guide born from real interviews and projects with Swiss and Liechtenstein SMEs. SME Digitalization Struggles: ❓ Overwhelmed by options? ❓ Limited budgets & time? ❓ Fear of team resistance? Our Solution: Follow the Leitfaden → Co-created with Univ. St. Gallen → Based on 50+ SME interviews → Examples from CH & LI In one session, a manufacturing boss shared how manual processes were eating 40% of his team's time. We applied the guide's effort-benefit matrix, prioritized quick wins like automated invoicing, and within weeks, they cut admin by 25%—no big budget needed. This isn't theory. It's a step-by-step roadmap: Understand your processes, prioritize with a simple matrix, build digital skills, and involve your team to avoid resistance. Key Framework: Effort-Benefit Matrix → Quick Wins: High value, low effort → Big Projects: Plan carefully → Avoid Time-Wasters Your Roadmap to Success (7-Step Plan): 1. Clarify purpose 2. Map current processes 3. Identify potentials 4. Gather inspiration 5. Define ideal state 6. Derive actions 7. Anchor changes Pro Tip: Optimize Before Digitizing → Fix workflows first → Involve your team early → Build digital skills while optimizing At MMIND.ai, we've used this framework to help SMEs like a cleaning firm automate HR and marketing, saving five-figure sums annually. The key insight? Optimize before you digitize. Fix broken workflows first, then add tech—otherwise, you're just automating chaos. Your takeaway: Grab the guide and audit one process this week. Map it out, spot bottlenecks, and pick a low-effort, high-impact fix. ♻️ Repost to help your network achieve success. And follow Hartmut Hübner, PhD for more. For further reading: Digital Transformation Strategies and Challenges in SMEs: https://lnkd.in/duhU2uCM Digital Transformation Strategies for Effective Business Management in SMEs (2025): https://lnkd.in/dk8ef8v7 Digital Transformation and SME Growth in Emerging Markets (2025): https://lnkd.in/d7J2mcQf #Digitalization #Transformation #SME #Innovation #AI #Culture

🚐 The Hidden Cost of Workarounds: When Broken Processes Drive Inefficiency 🚐 In many organizations, employees are forced to find creative workarounds to complete their tasks because the official processes are broken, outdated, or poorly designed. Instead of fixing the root cause, teams develop informal shortcuts to meet deadlines and fulfill KPIs. While these efforts keep operations running, they come at a hidden cost: inefficiency, inconsistency, and increased business risk. Why Do Workarounds Happen?🦠 Workarounds emerge when employees face obstacles that prevent them from following standard processes. These obstacles may include: • Outdated systems that don’t support business needs. 🖥️📀 • Siloed information that requires manual data transfers.⌨️💬 • Rigid processes that don’t account for real-world exceptions.🔮 • Lack of automation leading to time-consuming manual work.🤖 When employees can’t rely on formal processes, they improvise—often using Excel sheets, emails, or side agreements to bridge the gaps. 🚧 The Risks of Workarounds 🚧 While workarounds may seem like a necessary evil, they create significant risks for organizations: • Inconsistency – Different employees handle the same process differently, leading to errors. • Lack of visibility – Leadership loses insight into actual work execution. • Compliance issues – Unofficial methods may violate company policies or regulations. • Employee burnout – Constantly working around broken processes increases frustration and workload. ⛓️💥 From Workarounds to Process Excellence 👑 Broken process is broken promise to the Client. Organizations must shift their focus from quick fixes to sustainable process improvement. This requires: • Process and Task Mining – Analyzing how work is actually done to uncover inefficiencies. • Employee Involvement – Engaging teams to identify pain points and co-design better workflows. • Automation and AI – Reducing manual effort with intelligent process optimization. • Continuous Improvement – Creating a culture where process refinement is ongoing, not reactive. #Workarounds are a #symptom, not a solution. Organizations that proactively address process inefficiencies will not only improve performance but also empower employees to focus on value-added work instead of firefighting broken systems.

Simple Automation – Small Changes, Big Gains Automation doesn’t have to mean robots, AI, or huge investment. Sometimes, the biggest impact comes from the simplest forms of automation—the kind that removes repetitive tasks, reduces errors, and frees people up for higher-value work. That’s what we call Simple Automation. What Is Simple Automation? It’s about using basic tools, low-cost tech, or clever design to: ✔️ Remove manual steps ✔️ Reduce decision-making fatigue ✔️ Speed up routine processes It’s not high-tech—it’s smart design. Examples of Simple Automation 🔹 Excel Macros – Automating reports or data cleaning 🔹 Barcode Scanning – Instant data entry without typing 🔹 Auto-fill Forms – Reducing repetitive admin work 🔹 Drop-down menus – Preventing entry errors in systems 🔹 Sensors or limit switches – Triggering actions on machines without manual input 🔹 Jigs with built-in stops – Ensuring parts are positioned correctly every time Why Use It? ✅ Saves Time – Routine tasks are completed faster ✅ Reduces Errors – Standardized steps = fewer mistakes ✅ Improves Flow – Less interruption, more consistency ✅ Frees Up People – Employees spend more time on valuable work, less on admin Where to Start 1️⃣ Look for repetitive tasks done daily or weekly 2️⃣ Ask: “Could this be simplified or automated?” 3️⃣ Start small – one macro, one visual cue, one process improvement 4️⃣ Measure the time or errors saved 5️⃣ Share the success and build momentum Final Thought Automation doesn’t need to be complex to be effective. Start with the simple stuff—and scale as you go. Small wins add up fast.

Yesterday I posted a case study on how we reduced a client's time to contract and invoice by 30% and saved them 5-7 hours per week. Here's exactly how: After posting this yesterday, I'm receiving a lot of messages asking how we did it. I thought I'd make a post about this. Here's exactly how we did it: First, we mapped out the process. Before working with us, the company relied on a fragmented and unreliable system. Their order-taking, contracting, and invoicing processes lacked automation, leading to delays, errors, and a poor experience for both their team and clients. Then we optimized it. We designed a fully integrated workflow that begins with a Typeform order form, which feeds directly into Monday and Airtable to manage requests, generate contracts, and track invoices with a Softr interface for easy access to order updates and relevant documents. Then we implemented. The new system helped the sales team save approximately 5-7 hours per week by streamlining client intake and ensuring name cohesion across tools. It also reduced the time it took to send invoices and contracts by about 30%. Finally, we optimized again after implementation. Key features include automated contract and invoice generation, real-time order tracking, and a client-facing portal built with Softr. All of which improved efficiency, accuracy, and the overall client experience. The result? A centralized, user-friendly experience that eliminated manual steps and improved operational efficiency. The takeaway: Don't just automate. Optimize first, then implement, then optimize again based on real usage. Follow me Luke Pierce for more automation case studies like this.

This $1.2B firm was losing 60+ hours/month to disconnected systems. The more they grew - the slower they became. The fix? Simpler and cheaper than you'd think: Calderys operates in 100+ global markets. But behind the scenes? A mess of disconnected workflows and manual re-entry. Orders got stuck between systems. Customer complaints piled up. Teams scrambled to reconcile spreadsheets across 30+ countries. Classic enterprise paradox: success creates its own bottlenecks. But the real cost wasn’t time - it was agility. While teams cleaned up data, customers waited. While leaders hunted reports, opportunities slipped. Here’s how they turned chaos into scale... The transformation started with one principle: 👉 Compliance and ops shouldn’t require heroic effort. They should run on rails. Step 1: They mapped every workflow. Over 200 manual touchpoints emerged. One order touched 12 spreadsheets before it shipped. Step 2: They rebuilt those workflows inside Process Street. Now data flows automatically. Tasks trigger in sequence. Every step gets tracked - no chasing, no chaos. Step 3: They rolled out real-time dashboards. Country managers got hours back each week. Executives saw risk early and acted faster. 📊 In 6 months, Calderys achieved: • 60+ hours/month reclaimed • Manual errors eliminated • New market expansion without adding ops headcount • Audit prep time cut from 2 weeks to 2 hours • 40% faster employee onboarding The turning point? They stopped trying to fix everything. And started by automating one painful process: order intake. That win changed everything. They had thought the challenge was tech... It was change. Once people saw their daily pain disappear? They became their biggest advocates. And that’s what Process Street enabled: Simple, scalable, audit-ready workflows that drive real results. --- If you’re scaling fast but feel slower than ever... If operations still run on spreadsheets and hope... If audits, onboarding, and reporting all require heroics... You’re not the problem. Your system is. At Process Street, we’ve helped firms like Calderys turn operational drag into acceleration. Interested in finding out how we can apply the same for your organization? Drop me a message, or check out the link in the comments below!

How adopting automation in Segregation of Duties reviews improves accuracy and efficiency ⬇️ Embracing automation in your segregation of duties reviews can significantly enhance the accuracy and efficiency of the auditing process. By reducing manual intervention, you can minimize the chances of errors and streamline the review process, allowing for real-time monitoring and quick identification of potential conflicts. Automation enhances Segregation of Duties reviews by enabling you to: ➡️ Gather and analyze large volumes of data from various sources, reducing manual efforts and errors ➡️ Enable real-time monitoring for rapid identification of violations and suspicious activities ➡️ Apply predefined rules for consistent and standardized evaluations, reducing subjectivity ➡️ Handle increased data complexity, ensuring scalability as your organization grows ➡️ Rapidly flag potential violations and expedite identification ➡️ Generate comprehensive reports for effective communication with stakeholders and auditors ➡️ Minimize manual work, allowing you to focus on higher-value tasks Integrate with IAM systems for streamlined access management ➡️ Create audit trails for enhanced accountability and transparency ➡️ Adapt to changes in processes or systems, ensuring up-to-date reviews