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

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.

Read article: Audit Trail Review in Practice – What Really Matters?

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.

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