tl;dr: NIS2 was made to make Europe safer on the internet; however, many firms still find it hard to meet the rules. The reasons include wide scope, differences between countries, unclear local rules, legacy systems, staff gaps, and complex supply chains. Automation helps, yet it cannot fix weak policies, unclear responsibilities, or poor data. Below […]
tl;dr: Yes, warning letters and multiple inspections affect pharma stocks. They create risks like production disruption, export bans, recalls, legal costs, reputation loss, and delayed approvals. In recent years, big pharma companies have received warning letters that moved markets. Before investing, always check a company’s inspection history, warning-letter responses, recall records, and remediation plans. What
tl;dr: The FDA’s DSCSA ensures prescription drugs in the U.S. are traceable to prevent counterfeit or unsafe products. By 2025, all manufacturers, distributors, and most pharmacies must comply with serialization, verification, and tracing requirements. Businesses can use tools like Atlas Compliance to simplify compliance and protect the supply chain. The Drug Supply Chain Security Act
tl;dr: In 2025, inspections are tougher and often unannounced. Atlas AI Copilot helps QA teams see what each inspector focuses on, their common observations, and gives a step-by-step prep guide—so teams stay ready and avoid surprises. If you work in pharma or biologics, 2025 feels like the year inspections got real again. FDA is inspecting
Grasp the key meanings and uses of OOS in retail, technology, and transportation. See its business implications and learn effective management strategies. Explore now!
Discover what quality control is and the essential methods used. Learn about inspection, SPC, and tools like Pareto charts. Click to enhance your knowledge on ensuring continuous improvement in your industry!
Non-conformance costs more than compliance. Learn how to detect, manage, and prevent it before it leads to inspection failures.
Changes in a project vary in nature. Some are unexpected, such as weather delays or illness, while others are formally requested. Regardless of how they arise, each change must be carefully evaluated and either accepted or rejected. Once a change is approved, it initiates a structured change control process to help ensure the project stays
Regulations in pharmaceuticals, life sciences, and biotech demand unwavering compliance and a focus on continuous quality improvement. One of the most persistent challenges faced by Quality Assurance and Regulatory Affairs professionals is implementing a truly effective CAPA (Corrective and Preventive Action) program. While the concept of a CAPA program is widely recognized as essential for
When a defect or nonconformity arises in a product, it can disrupt supply chains, impact customer trust, and lead to significant operational delays. One of the key challenges businesses face is not just identifying these issues, but ensuring they are resolved at the root level and prevented from recurring. This is where a Corrective Action
