There’s a particular kind of silence that fills a regulatory office the week before an audit. It’s not calm. It’s the silence of a team holding its breath. Everyone is double-checking documents. Hunting down final versions. Re-reading familiar lines with unfamiliar urgency. The scramble is on. If this feels normal, that’s the problem. Fire-drill culture […]
In the world of MedTech regulatory operations, chaos has become strangely normalized. Audit season feels like a countdown to disaster. Submissions rely on scattered files, last-minute reviews, and a best-guess approach to which document holds the latest approved content. It is not sustainable. And it is not the only way. For Regulatory Affairs, Quality Managers, […]
Original article on ITnation: « Mieux gérer l’information, pour mieux performer » We were delighted to be featured in a series of articles published by ITnation. In this first article, Giuseppe Contino, Managing Director of AmeXio Group, looks back on our growth in Luxembourg and our commitment to supporting the digital transformation of businesses. “Document […]
As a European organization, you’ve likely given serious thought to how and where your data is hosted. But in today’s rapidly evolving digital and geopolitical landscape, it’s no longer just about performance or cost—it’s about control, compliance, and long-term resilience. Have you considered what it truly means to go fully European with your cloud infrastructure? […]
There’s a quiet moment in every regulatory team I’ve worked with—a moment right before a submission goes out the door. Someone stares at a file and whispers: “Is this the right version?” And that single question sums up an entire industry problem. We’re Not Just Managing Documents. We’re Managing Fear. Regulatory teams are some […]
There’s a particular tension you can feel inside any MedTech regulatory or quality team during audit season—and let’s be honest, that season never really ends. The binders get thicker. The spreadsheets multiply. And somewhere in the back of everyone’s mind is that nagging question: “Did we update that one section in all the places it […]
If you’re part of a medical device company, you already know the pressure: regulatory deadlines that shift overnight, multilingual labeling updates that never quite sync, and documentation systems that still rely on copy-paste and spreadsheets. And amid all that, you’re still expected to move fast. At AmeXio, we’ve seen how the way content is managed […]
In today’s digital-first business landscape, the demand for speed, accuracy, and scalability has made workflow automation not just a convenience but a necessity. Whether you’re processing invoices, onboarding employees, or managing large volumes of customer data, automation helps reduce manual effort and increase operational efficiency. What is Workflow Automation? Workflow automation refers to the […]
The financial sector is under pressure. Banks, insurers, and financial service providers are facing rising compliance demands, increasing cyber threats, and customers who expect speed and transparency. In this context, electronic invoicing (e-invoicing) is not a luxury, it’s a critical step towards modernizing the financial back office. Where paper invoices and PDFs cause delays, errors, […]
Every business relies on assets, whether it’s a factory full of machines, a fleet of company cars, or just the office furniture at headquarters. These valuable resources help your organization operate, produce, and grow. But to get the most out of your assets, it’s not enough to just own them. You need to manage them […]