About
I help pharmaceutical supply chain companies design and implement better digital supply…
Articles by Daniel
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The Interoperability Tax
The Interoperability Tax
Why the Key to AI Adoption is True Interoperability TLDR | DSCSA December 2025 Since DSCSA became law, the country has…
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TLDR | DSCSA September 2025
TLDR | DSCSA September 2025
Dispensers are facing the last mile, some still waiting on data. September’s Partnership for DSCSA Governance (PDG)…
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TLDR DSCSA | August 2025
TLDR DSCSA | August 2025
Small Distributors Step Into the Spotlight TLDR ⚡ August 27, 2025, marked the official end of the DSCSA exemption…
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How a Small Pharmaceutical Distributor Shook America's Drug Chain
How a Small Pharmaceutical Distributor Shook America's Drug Chain
Once a little‑known wholesaler, Sterling Distributors compliance failures triggered counterfeit drugs, subpoenas and a…
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TLDR DSCSA | June 2025 🌞
TLDR DSCSA | June 2025 🌞
The Future of DSCSA Belongs to the Technically Fluent. The DSCSA at its core is a data problem.
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TLDR DSCSA | May 2025 🌻
TLDR DSCSA | May 2025 🌻
May Brings More Than Flowers April showers bring May flowers but in 2025, May also brings the Drug Supply Chain…
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TLDR DSCSA | April 2025 🐣
TLDR DSCSA | April 2025 🐣
The most interesting DSCSA stories and news for the month of April. Learn about the latest milestones, tools, and…
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CBV Explained: How EPCIS Gets Its Meaning
CBV Explained: How EPCIS Gets Its Meaning
By Daniel Kraciun , Chief Marketing Officer @ Trust.med Course Introduction Welcome to the EPCIS Analyst Basics Course,…
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TLDR | March 2025 ☘️
TLDR | March 2025 ☘️
The most interesting DSCSA stories and news for the month of March. This month, we learn about FDA’s OAI classification…
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EPCIS Event Structure
EPCIS Event Structure
Introduction to the Course Welcome to the EPCIS Analyst Basics Course. EPCIS is not just a technical standard, it's a…
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Activity
8K followers
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Daniel Kraciun shared thisWhy are we plain text emailing passwords for #DSCSA data portals? Migrate away from platforms like this. If your consultancy, sales rep, or strategic advisor is recommending that you utilize a regulated data system that is plain text pasting user passwords in unencrypted emails...your liability is through the roof. Maybe release an AI solution to solve the problem. OR Build systems that meet the demands of a secure supply chain. Regulations can't fix bad technical architecture and practice.
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Daniel Kraciun shared this"The meek shall inherit the earth, but they'll never increase market share" -William G. McGowan
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Daniel Kraciun shared this"The question was never whether to use AI. It was always about building the right architecture around it." - from the comments Erez nails the perspective on the 'AI warning letter'. It should be used as a design spec for implementation. Build the right architecture, which includes people, and then implement supporting technology to solve the problem at hand.Daniel Kraciun shared thisMost people read last week's FDA warning letter as a cautionary tale about AI. I read it as a design spec. For the first time, the FDA told the industry what compliant AI looks like inside a regulated lifecycle. The letter isn’t about a bad actor or bad AI. It is about using AI without human oversight built into the architecture. These are completely different problems. 🔍 𝗛𝗲𝗿𝗲'𝘀 𝘁𝗵𝗲 𝗮𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗹𝗲𝘀𝘀𝗼𝗻 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗶𝘀 𝘁𝗲𝗮𝗰𝗵𝗶𝗻𝗴 𝘂𝘀: The FDA is enforcing a chain of custody for AI-generated outputs. All records must follow 21 CFR Part 11 (or Annex 11 in the EU), meaning a qualified human review with an e-signature, timestamp, version lock, and audit trail. This quote says it best: "𝘢𝘯𝘺 𝘰𝘶𝘵𝘱𝘶𝘵 𝘰𝘳 𝘳𝘦𝘤𝘰𝘮𝘮𝘦𝘯𝘥𝘢𝘵𝘪𝘰𝘯𝘴 𝘧𝘳𝘰𝘮 𝘢𝘯 𝘈𝘐 𝘢𝘨𝘦𝘯𝘵 𝘮𝘶𝘴𝘵 𝘣𝘦 𝘳𝘦𝘷𝘪𝘦𝘸𝘦𝘥 𝘢𝘯𝘥 𝘤𝘭𝘦𝘢𝘳𝘦𝘥 𝘣𝘺 𝘢𝘯 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘻𝘦𝘥 𝘩𝘶𝘮𝘢𝘯 𝘳𝘦𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘢𝘵𝘪𝘷𝘦 𝘰𝘧 𝘺𝘰𝘶𝘳 𝘧𝘪𝘳𝘮’𝘴 [𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘶𝘯𝘪𝘵 (𝘘𝘜)]" The FDA isn’t telling you to use AI less. They’re telling you how to use it. 🔄 𝗪𝗲’𝘃𝗲 𝗯𝗲𝗲𝗻 𝗵𝗲𝗿𝗲 𝗯𝗲𝗳𝗼𝗿𝗲. In the early 2010s, quality leaders across life sciences said the cloud was incompatible with compliance. They were wrong, and the companies that waited fell behind. The answer was never to avoid the cloud. It was to establish the right controls, validate your deployments, and document what's required. AI is at the same inflection point. The FDA just revealed exactly what teams can do to get a two-year head start on anyone who waits for the regulation to “stabilize.” The waiting period is over. 💡𝗧𝗵𝗿𝗲𝗲 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 𝘄𝗼𝗿𝘁𝗵 𝗯𝗿𝗶𝗻𝗴𝗶𝗻𝗴 𝘁𝗼 𝘆𝗼𝘂𝗿 𝘁𝗲𝗮𝗺: 1️⃣ Can we produce the full custody chain for any piece of AI-generated content in our regulated records? 2️⃣ Can we show that none of our AI outputs reach a controlled state without a qualified human review? 3️⃣ Are we taking a risk-based approach to where AI shows up in our lifecycle? If any of those answers is uncertain, the work is architectural, not in model selection.
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Daniel Kraciun posted thisTrust.med has a newsletter now... Its a monthly briefing that's part TLDR and part insider signals. The first newsletter is live. Read it and subscribe here: https://lnkd.in/ea5d_YaR
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Daniel Kraciun reposted thisDaniel Kraciun reposted thisThis is a little technical, but it is important for all of my fellow service/technology providers who utilize APIs... Axios, a widely used JavaScript library for making HTTP requests, was recently compromised, allowing for the installation of a RAT (Remote Access Trojan) onto the affected system and destroying any trace that it even existed. Engineers should be taking a moment to look at their package dependencies, especially if you use Node or make HTTP requests directly in browser for small pages. The affected tags for the Axios package are 1.14.1 and 0.30.4. The attacker hijacked the main Axios maintainer's account, and used this to add a small addition to the latest builds without triggering build reviews. They added a "plain-crypto-js@4.2.1" package to the build. This package downloaded and installed the RAT based on the operating system of the compromised system. It then would go through and delete the malicious setup.js, swapping plain-cryptos code and switching out the package.json for something clean. If you do use this, make sure you change all passwords and rotate any keys that may have been transmitted over the breached system. Stay safe.Axios Supply Chain Attack Pushes Cross-Platform RAT via Compromised npm AccountAxios Supply Chain Attack Pushes Cross-Platform RAT via Compromised npm Account
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Daniel Kraciun posted thisThere is a lot of negative brand equity being built by DSCSA right now. Trading partners are evaluating each other in a new light. If your solution provider is struggling, they’re representing you to your customers and suppliers. Your technical stack is now part of your reputation. We’re fortunate to work closely with partners like: -AltiusHub -OPTEL Group -TrackVision AI -Kvinta -Jennason LLC -ANKHERO and others who are deeply focused on improving digital supply chains. The difference is immediate. Years of operational pain disappear. Pricing becomes rational again. Support actually helps. Partners stop dreading integrations. The next phase of DSCSA is actually 'who is easy to do business with.'
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Daniel Kraciun posted thisWhere are all the useful AI agents? Send links...
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Daniel Kraciun shared this'This is the interoperability tax that slows down innovation and prevents organizations from modernizing their technology stacks, specifically with AI.' AI messaging is taking over DSCSA technology vendors websites... It's probably a good time to revisit interoperability.
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Daniel Kraciun shared thisPharmaceutical manufacturing has a network scaling problem and it’s directly impacting the industry’s ability to stay compliant. The complexity and cost of trading partner connectivity have gotten out of hand. Companies are being penalized for growing their supply chains. Back orders pile up because connectivity takes weeks. And vendor lock-in means that switching serialization providers requires rebuilding an entire digital ecosystem from scratch. Is that in the trading partner’s best interest? This is not interoperability. It’s a network model designed with commercial benefit for the provider, not operational flexibility for the manufacturer. Why should you be penalized for switching serialization providers? A modern data exchange network should allow trading partners to move fluidly between technology providers, eliminate the burden of rebuilding integrations, and reduce both cost and downtime. This isn’t a novel idea. It’s how we support our customers every day. Connect once. Exchange everywhere. No per-connection fees. No limits on partners. No lock-in. Your network moves as you move. It’s not novel. It’s Trust.med. #DSCSA
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Daniel Kraciun liked thisDaniel Kraciun liked thisA buddy sent me this picture the other day and said: “Your son is out here hustling.” I stopped for a second. Because that is exactly what it is. My son and his friend started a garbage can cleaning business in the neighborhood. No big launch. No fancy plan. Just an idea… and the willingness to go knock on doors and figure it out. Watching it from a distance has been pretty cool. Loading up the wagon. Figuring out pricing. Talking to neighbors. (Being told NO a bunch) Learning in real time. No shortcuts. No handouts. Just effort. As a parent—and honestly as a business owner—it is a reminder: You cannot teach this stuff in a classroom. Confidence comes from doing. Resilience comes from hearing “no.” Growth comes from showing up again anyway. Proud dad moment. But more than that… I respect the work.
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Daniel Kraciun reacted on thisDaniel Kraciun reacted on thisFor a long time, serialization was one of the pharmaceutical industry’s largest and most disruptive digital transformations. I spent close to a decade working in this space within a CMO environment, including leading the deployment and implementation of global serialization systems and processes across manufacturing operations. Looking back on that experience now, with a broader digital and data perspective, I’ve found myself reflecting on what serialization actually taught us about operational maturity, governance, interoperability, and the long-term sustainability of digital systems. One of the biggest realisations for me is that delivering under pressure is not the same thing as building maturity by design. Many organisations successfully implemented serialization. But in doing so, they also accumulated technical debt, fragmented workflows, disconnected data structures, and operational drift that still exists years later. This article (click the image below) explores that tension between firefighting and governance, and why I believe the next generation of digital maturity in CMOs will depend less on implementing new technologies, and more on how well organisations sustain alignment between systems, workflows, data, and operational intent over time. A huge thank you to Justin Ahdan at ANKHERO for the many discussions that helped shape and challenge my thinking while writing this piece. His perspective around interoperability, governance, and data ownership added a huge amount of depth to the conversation. #Pharma #Serialization #DigitalTransformation #CMO #DigitalMaturityFrom firefighting to governance: What serialization taught us about digital maturity in CMOsFrom firefighting to governance: What serialization taught us about digital maturity in CMOs
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Daniel Kraciun reacted on thisConsider these statements as gospel when applied to pharma serialization. “AI is a force multiplier. And if you multiply weak foundations, you don't get transformation, you get bigger problems, faster…” could not be more accurate for current-state serialization capabilities built on legacy platforms. “Garbage data in, confident garbage out, at scale” reflects what is likely the single greatest barrier to meaningful AI adoption in pharma serialization today. And this point is the call-to-action that many pharma serialization decision makers don't want to admit to: “‘We added AI’ is often the headline that lets leadership avoid the harder conversation. The one about refactoring. Replatforming. Retiring systems that should have been retired five years ago.” Be mindful of legacy serialization vendors positioning AI as the new shiny object to distract from poor interoperability, weak data quality, and foundational platform issues that still need to be solved. “The right sequence has never changed: Fix the foundations. Then add intelligence on top. AI doesn't rescue broken infrastructure. It exposes it.” We dove deep into many of these same themes on the latest episode of the Decommissioned podcost with ANKHERO https://lnkd.in/eyMP85pk #epcis #serialization #gs1 #dscsa
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Daniel Kraciun reacted on thisDaniel Kraciun reacted on thisA foundational process for many supply chain applications is first-in-first-out (or FIFO), i.e. consuming resources in the order in which they were produced. Food waste and food safety are obvious use case examples. I found it interesting that this week's reading from Leviticus of the Jewish Torah (Old Testament) includes an admonition to practice FIFO principles. Ancient wisdom for modern times! #FIFO #supplychaintraceability TrackVision AI #torah #oldtestament
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Daniel Kraciun reacted on thisDaniel Kraciun reacted on thisHot take: There's never been a medically justifiable reason to compound GLP1 products. The practical reason many people do it is for cost. That's fine in theory, but cost is not a justifiable reason under the law as it subverts intellectual property laws. Original post Dave Knapp
Experience
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Education
Licenses & Certifications
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Full Stack Software Development
MIT Professional Education
IssuedCredential ID 0x49d261ae3025a07bb1cc86daba1d6fdf2740cfea03cb30979bbe9e0d59a6f72b -
Patents
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System for Resolving Domain Names on the Internet
Issued 12,461,983
See patentTo address the challenges with managing a pharmaceutical drug supply chain, a system for GTIN resolving domain names in the format GTIN.gTLD, or similar, is described herein, including the functionality of a single registrant gTLD registry database adapted to contain one or more second-level domains including the GTIN, and a DNS adapted to resolve one or more nameservers retrieved from the registry database.
Honors & Awards
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40 Under 40 Award Recipient
Crains Cleveland Business
Crains Cleveland Business 40 under 40 award recipient. Crains 40 under 40 classes honors forty business and community leaders under the age of forty doing innovative and impactful work in their cities.
https://www.crainscleveland.com/awards/2022-forty-under-40 -
Great Comebacks - Ina Brudnick Central Regional Award
CCFA
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Many SaaS sales pitches lose deals before they even get to the demo. Here’s why. Your SaaS pitch isn’t a demo. It’s a decision point. 𝗔𝗻𝗱 𝘁𝗼𝗼 𝗺𝗮𝗻𝘆 𝘁𝗲𝗮𝗺𝘀 𝗹𝗼𝘀𝗲 𝘁𝗵𝗲 𝗱𝗲𝗮𝗹 𝗯𝗲𝗳𝗼𝗿𝗲 𝘁𝗵𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗲𝘃𝗲𝗿 𝘀𝗵𝗼𝘄𝘀 𝘂𝗽. The most common mistakes we see: Starting with a monologue Selling features, not solving a problem Forgetting to prove you’ve done this before Most teams also miss the importance of how they open and close the call. Both are dealbreakers. We break it all down in this article (🔗 in the first comment).
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SOLVD.cloud
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