anic Blog

The First FDA Warning Letter Referencing AI: Why the Failure Was Not the Technology, but the Lack of Control

The first FDA Warning Letter explicitly referencing the use of Artificial Intelligence is making waves across the industry. But a closer look reveals: the failure was not the technology itself, but the lack of control around it. Missing validation, insufficient documentation, and poor process integration — the actual weaknesses are well-known GMP issues.

Warning Letter analyzed in detail

We're featured in phpro – Interview with Andreas Nicklas

Yes — we're featured in phpro. And most importantly: we're not only addressing those who are already producing in a fully digital environment. In practice, a large number of pharmaceutical manufacturers — around 60–70% — are still working with paper-based batch documentation. That is exactly why the interview with Andreas Nicklas is worth reading: it explores how to approach the move toward digitalization in a pragmatic way — and why change must never become a bottleneck in the process.

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The Path to the Agile Lab: Why Traditional EBR Systems Are Slowing Down the Pharmaceutical Industry—and How to Break Free

Why do recipe changes in your production still take months? While the market demands agility, rigid EBR systems slow down innovation. Discover how to break free from the "golden cage"—from paper chaos through digital bottlenecks to true production agility in hours instead of quarters.

A way out of the dilemma?

Audit Trail Review in Practice

Audit trail reviews are more than a compliance exercise – they are crucial for data integrity and compliance in pharmaceutical production. However, many companies face challenges in practice: confusing raw data, missing filters, and time-consuming manual reviews.

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AUTOMA+ 2025: The future of the pharmaceutical industry starts here

As Gold Sponsor of AUTOMA+ 2025, we not only present our expertise but actively shape digital transformation. On November 24-25, 2025, industry leaders meet at the Eventhotel Pyramide & Congress Center in Vösendorf, Austria.

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Partnership with Quark – Together we shape the future of document automation

anic and Quark join forces to redefine document automation in regulated industries. Discover how this partnership combines innovation and efficiency.

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Agile Upscaling in the Pharmaceutical Industry

Agile upscaling in the pharmaceutical industry: How anicomply revolutionizes digital documentation and supports GxP-compliant processes flexibly and efficiently.

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Excellence in Manufacturing – Validation of computer systems for use in pharmaceutical production – Part 1

Computer System Validation (CSV) plays a central role in regulated industries such as pharmaceuticals, biotechnology, and medical technology. The focus is on patient safety, product quality, and data integrity, as well as operational efficiency and regulatory compliance.

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