Atlas Compliance Blog

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 […]

Ensuring quality and compliance in the pharmaceutical industry is more challenging than ever. Companies face increasing regulatory scrutiny, complex global supply chains, and pressure to avoid quality issues that risk patient safety or delay production. A major weak point is the supplier network, where unqualified suppliers can cause violations, poor materials, and costly recalls. However, […]

The Food and Drug Administration (FDA) acts as the vigilant guardian of public health, issuing over 4,000 Form 483s in FY 2024, with the food area leading the way. For businesses in the pharmaceuticals, medical devices, food, and tobacco industries, the FDA’s regulatory reach is ever-present. A significant tool in their enforcement arsenal is the […]

Staying compliant with FDA regulations can be challenging, especially when inspection outcomes are complex and unclear. For regulated companies, understanding FDA inspection classifications is key to managing risk and staying audit-ready. We recognize that interpreting FDA inspection results and keeping up with shifting regulations can feel overwhelming for MedTech, pharmaceutical, and life sciences companies. Staying […]

For pharmaceutical, food, and medical device companies, staying compliant with FDA regulations is a constant challenge. Even minor oversights can result in serious consequences. One of the most severe outcomes is receiving a consent decree from the FDA, which can lead to production shutdowns, hefty fines, and long-term reputational harm. During this period, businesses may […]