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 […]
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 […]