Atlas Compliance Blog

Companies in the pharmaceutical, biotech, and food industries must ensure their products remain consistently safe, effective, and compliant with public health standards. Maintaining this level of quality presents a significant challenge, as it requires rigorous oversight of every stage in the manufacturing process. To meet these demands, manufacturers rely on Current Good Manufacturing Practices (cGMP). […]

FDA QSIT inspection readiness is often a major source of stress for companies in regulated industries, largely due to the high stakes and complex requirements involved. Many businesses are caught off guard not by what’s inspected but by how quickly the process begins the moment an FDA inspector walks through the door. From presenting credentials […]

Pre-Approval Inspections (PAIs) are high-stakes checkpoints in FDA-regulated industries that can significantly impact product approval and market entry. Many companies, regardless of size or past experience, often find themselves unprepared for the depth and rigor of a PAI. We understand that facing a pre-approval inspection FDA can feel daunting and stressful, especially given the complexity […]

Regulatory requirements in the medical technology (medtech) and pharmaceutical industries demand constant attention. For quality, compliance, and operations teams, tracking changes to FDA regulations can be a daunting task. Especially when faced with an FDA Form 483 database. These inspection reports identify potential violations and often require immediate corrective actions that can disrupt workflows and […]

Effective document management is essential for businesses across industries, especially in sectors like pharmaceuticals, where regulatory compliance plays a critical role. One of the most efficient ways to handle and organize vast amounts of regulatory documents is through an Electronic Document Management System. According to a study by MarketsandMarkets, the global Document Management Systems market […]

The Supplier Corrective Action Request (SCAR) process is crucial for product quality and supplier accountability in Quality Management Systems (QMS). It identifies and addresses nonconformance in products or processes to prevent recurrence, supporting continuous improvement. This process is crucial in regulated industries such as pharmaceuticals, medical devices, and manufacturing, where the quality of materials impacts […]

In October 2020, KVK-Tech, a pharmaceutical manufacturer, received a stern warning from the FDA. This was not the first time the company had been under scrutiny.  The FDA conducted over 1,000 inspections in 2020 alone, with companies receiving warning letters for failing to meet regulatory standards. Despite previous warnings, KVK-Tech was found to have multiple […]

In an industry known for medical innovation, the pharmaceutical sector also faces growing scrutiny over its environmental impact and compliance responsibilities. While drug safety dominates headlines, environmental regulatory compliance is becoming just as crucial for long-term operations and corporate responsibility. The industry emits nearly 52 megatons of CO₂ annually, equivalent to the pollution from 11 […]

An Establishment Inspection Report is created after FDA investigators inspect facilities involved in manufacturing, processing, or distributing FDA-regulated products. More than just a summary, the EIR is a critical tool used by both the FDA and regulated entities to assess compliance, address operational risks, and implement meaningful improvements. In this article, we’ll explain everything you […]

Facing an FDA inspection? For businesses in regulated industries such as pharmaceuticals, medical devices, or food production, that moment can define compliance success or expose critical gaps. Long before warning letters are issued, the FDA flags violations through Form 483 observations, formal reports that highlight non-compliance discovered during inspections. In FY 2024 alone, the FDA […]