Atlas Compliance Blog

Quality Assurance (QA) teams are the silent guardians of compliance in regulated industries. Yet, many organizations overlook the key metrics that reflect not just product quality but regulatory readiness. This article explores essential QA compliance metrics, their strategic value, and how modern tools like Atlas Compliance can bridge the gap between reactive and proactive compliance. […]

Getting hit with an FDA Form 483 should be a wake-up call. As these observations are often made public, your company is under a tangible risk of losing reputation and consumer trust. An effective response is critical at this stage, as failure can lead to product approval suspensions and delays that impact revenue as well […]

In the pharmaceutical industry, even minor oversights can lead to significant compliance failures. The Corrective and Preventive Actions (CAPA) process is essential in mitigating these risks and forms the backbone of a robust Quality Management System (QMS). However, many pharmaceutical manufacturers still struggle with effective CAPA implementation. FDA inspection data reveals that inadequate or missing […]

In pharma, compliance is essential for your business. When the FDA conducts inspections, being unprepared is not only risky but also costly. The FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. Many of these inspections result in Form 483s and warning letters, often due to avoidable […]

Understand the key elements of GxP compliance to help ensure product safety, stay aligned with regulations, and avoid costly penalties in the life sciences sector.

Pharmaceutical regulatory compliance is a critical and growing part of the industry. The U.S. pharmaceutical regulatory affairs market is expected to reach over $2.4 billion by 2030, growing steadily at nearly 8% annually from 2024.  This growth highlights how important it is for pharmaceutical companies to manage compliance, both to meet strict safety standards and […]

tl;dr: FDA inspections are not just regulatory checkpoints but critical evaluations of your quality systems, documentation, and risk posture. Whether it’s a routine inspection, a for-cause audit, or a pre-approval inspection, here are 100 essential elements that FDA inspectors often review in the FDA compliance checklist. 1–20: Data Integrity & Documentation (21 CFR Part 11 […]

In the life sciences industry, product quality and regulatory compliance are non-negotiable. When deviations occur, organizations must act quickly and effectively, not just to fix the issue but to ensure it never happens again. This is where CAPA comes into play. In this definitive 2025 guide, we’ll break down everything you need to know about […]

In 2025, the Center for Biologics Evaluation and Research (CBER) approved a series of groundbreaking biological products and devices, each contributing to advancements in healthcare and patient safety. Below is an overview of notable approvals and regulatory developments during this period. Biological License Application (BLA) Approvals Automated C3d Plate (Anti-Human Globulin, Murine Monoclonal) Noteworthy BLA […]

The medical device industry operates under strict regulatory oversight to ensure product safety and effectiveness. The U.S. Food and Drug Administration (FDA) is pivotal in establishing and enforcing compliance standards. In 2023 alone, the FDA issued over 1,200 warning letters related to medical device compliance, highlighting the increasing scrutiny of manufacturers. Staying informed about these […]