Software Validation Processes

Just validate the software!  Sounds simple but at a medical device company there are many types of software that need to be validated and the rules and requirements are different for each type. I put together this diagram of the “software landscape” to help people understand what type of software they’re working with. The diagram shows all the categories and sub-categories of software at a medical device company with examples of each type. First, we divide the landscape into product software and “non-product software.” Product software, if it’s regulated, falls under FDA design control regulations and international standards for medical device development such as IEC 62304. Product software includes all the software you develop plus any third party software included in your product. Within the regulated product software category there are three sub-categories based on the safety risk of the software (classes A / B / C per the IEC 62304 medical software standard). The fourth category “Enforcement Discretion” refers to low risk applications that are technically regulated by FDA but for which FDA has decided not to enforce regulations. On the non-product software side different regulations and standards apply and therefore different requirements for validation and documentation. There are three main sub-categories of non-product software: software used in manufacturing, software used in product development, and software used in the quality system. These can vary considerably in complexity and risk profile, including everything from an Excel spreadsheet to a software test script to a very complex PLM system. The testing and documentation required for validation of non-product software depends very much on the risks associated with them and their complexity (i.e. a one-size-fits-all approach to validation will either over-validate or under-validate the wide variety of non-product software). My recommendation is to follow the FDA guidance for “Computer Software Assurance for Production and Quality System Software” and the international guidance ISO/TR 80002-2:2017 “Validation of software for medical device quality systems.” See links in the comments below. Do you have any tips for managing the variety of regulated software at a medical device company? What has worked well (or badly) at your company? #medicaldevices #medicalsoftware #samd

Validation doesn’t need to be transformative to be effective—it just needs to be smart. Think of it as hitting the reset button on how you approach software validation in pharma: 1. Focus on What Matters: Zero in on patient safety, product quality, and data integrity if a system tracks impurities in a drug batch, test that rigorously—don’t waste time on low-risk features like UI colors. 2. Shift Your Team’s Mindset: Move from checking every box to assessing risks. Ask: “What failure could harm the patient or break compliance?” 3. Ditch Endless Scripts: Replace exhaustive test scripts with focused, risk-driven ones. CSA isn’t about less work—it’s about better work. What I See in Practice: - Every company adapts at its own pace—some leap to AI-driven testing, others tweak existing processes. - Resistance is real, especially from teams married to “test everything” habits. They fear regulators won’t buy it. - Most teams who pivot see gains—think 20-40% less documentation and sharper quality focus within months. The Big Question I Get: “Will regulators accept this?” My response: They will if you prove it works. Show them a risk profile, targeted tests, and solid outcomes—not just a pile of papers. How to Start: - Use the FDA’s CSA draft guidance—prioritize risks over routine testing. - Map your system’s impact on safety, quality, and data—then test accordingly. - Streamline documentation to show how it works, not just that it does.

Beyond IQ/OQ/PQ: What Really Drives Compliance? IQ/OQ/PQ is just one part of the validation process. But if you think compliance ends there, you’re missing the bigger picture. I’ve seen companies meticulously execute IQ/OQ/PQ, only to fall out of compliance within months because they ignored: ✔ Change Management – How do you handle system updates, patches, or new configurations? If changes aren’t controlled, your validation quickly becomes obsolete. ✔ Training & User Adoption – A validated system is useless if end users don’t follow procedures or misunderstand system controls. A lack of proper training is a fast track to data integrity issues. ✔ Continuous Monitoring – Periodic reviews, system audits, and performance checks ensure that compliance isn’t just a one-time event. A system that was compliant last year may not be today. IQ/OQ/PQ is just the starting point. True compliance comes from maintaining validated systems, not just checking a box. 👉 What’s your take? Have you seen companies focus too much on validation paperwork while neglecting the ongoing processes that actually drive compliance? Let’s discuss.

Stop Rebuilding Ships: The Vendor Documentation Secret Most CSV Teams Miss. I've seen this mistake in 100+ pharma and biotech projects, and most of us are not sure why we still do this way. CSV teams blindly rewrite EVERYTHING from scratch: • New URS • New FS • New IQ/OQ • Weeks testing what vendors already validated Then they wonder why validation is so heavy, slow, and expensive! Here's my take: If you're not leveraging supplier documentation properly in 2025, you're doing CSV wrong. Why? Because vendors have already done 60-70% of the work! They've created: • Functional Specs • Design Specs • IQ/OQ Protocols • Release Notes • Config Guides • Cybersecurity Assessments • Sometimes even 21 CFR Part 11 justifications So why are we rebuilding the same ship? Because many still operate with a 1990s validation mindset—doing everything themselves for the illusion of control. We don't need that anymore. We need Smart CSV. Risk-Based Validation. CSA thinking. What you SHOULD be doing: • Audit the vendor's SDLC and quality processes • Evaluate documentation for GxP relevance • Leverage what's robust, supplement what's missing • Call it out clearly in your Validation Plan • Maintain traceability from YOUR requirements to THEIR docs Here's what that sounds like in a Validation Plan: "The supplier's IQ and OQ documentation will be leveraged post-QA review. Additional site-specific PQ testing will be performed to verify fitness for intended use in the GMP environment." Simple. Clean. Risk-justified. My stance: If your CSV team isn't leveraging supplier documentation strategically, you're overspending, overcomplicating, and setting yourself up for audit pain. In the world of Computer Software Assurance, efficiency isn't optional—it's expected. It's time to stop validating out of fear and start validating with intelligence. I teach this inside my CSV-GameChanger Academy. This one shift (vendor leverage) has saved my students weeks of time and thousands of dollars for the customers they serve. Drop a ✅ in the comments if you're ready to stop doing extra work for no reason and start validating like it's 2025. Or DM me to join our next batch.

ISO/TR 80002-2: Save a Lot of Time on QMS Software Validation Software validation is a critical requirement for medical device manufacturers. This is especially true under ISO 13485. But when it comes to validating software used in a QMS, the process can seem overwhelming. This is where ISO/TR 80002-2 comes into play. It’s a technical report that provides practical guidance for validating QMS software. It offers a framework for checking whether your tools meet both regulatory and operational requirements. But why is this document so essential and helpful? Here are 5 key reasons why ISO/TR 80002-2 should be the foundation of your software validation strategy: 1. Structured Validation Process ↳ Defines clear steps for validating software, from planning to execution. ↳ Is tailored for Software used in QMS and provides examples. ↳ This improves compliance without overburdening resources. Focus on Risk Mitigation ↳ Builds a strong foundation by identifying software-specific risks. ↳ Incorporates principles from ISO 14971, creating alignment ↳ Ensures safety and reliability remain central to your QMS processes. Versatility Across Tools ↳ Applies to all QMS software, from CAPA systems to document control. ↳ Offers flexibility to adapt validation practices to software environments. ↳ Simplifies compliance with standards, regardless of the tool’s complexity. Simplified Documentation Requirements ↳ Reduces the complexity by outlining what’s necessary—and what’s not. ↳ Minimizes time spent on creating excessive paperwork without structure. ↳ Offers templates and examples to accelerate the validation process. Regulatory Readiness ↳ Aligns validation activities with ISO 13485 and MDR expectations. ↳ Strengthens ability to demonstrate control during audits and inspections. ↳ Protects the manufacturer from potential compliance issues. By following the standard, you can avoid common pitfalls: → Under- or over-validating software. → Wasting time and resources on ineffective processes. → Missing compliance expectations during audits. With this technical report, software validation becomes structured, efficient, and compliant. It’s the perfect starting point for anyone looking to improve QMS software validation practices. P.S. Are you using ISO/TR 80002-2 for your software validation? If not, what’s your approach? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I’m Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let’s connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices