Annual Product Reviews (APRs) are not just a regulatory requirement. They are a valuable quality management tool. An APR helps companies understand the overall performance of a drug product, detect trends, and identify areas that may need improvement
Concrete and Masonry Construction Injuries in the U.S.: A Statistical Snapshot
⚠️ Concrete & Masonry Safety Risks Concrete and masonry work is essential for building strong foundations, walls, and structures. But this type of work also comes with serious risks. Workers in these trades face some of the hig
How FDA Inspects Computerized Systems Under cGMP: A Legal Overview
Computerized systems play a key role in today’s pharmaceutical and biotech industries. From data recording to equipment control, they help maintain quality and consistency. But with more use of digital systems comes closer inspection by the U.S. Food
Heatwaves and Server Room Safety: Environmental Controls to Protect Computerized Systems
Extreme heat can damage more than just outdoor equipment. When a heatwave hits, even indoor areas like server rooms can suffer. For companies relying on validated systems and digital documentation, the impact can be serious. Systems can slow down, ov
Safe Handling of Gas Cylinders in Laboratories (USA): A Guide for Technicians and Researchers
Gas cylinders are a common part of daily work in many laboratories across the United States. Whether you're working with oxygen, nitrogen, carbon dioxide, or more hazardous gases, proper handling is critical. Mistakes can lead to serious injuries, fi
How to Store Compressed Gas Cylinders Safely – A Simple Checklist
Compressed gas cylinders are common in many workplaces. You’ll see them in labs, factories, hospitals, and construction sites. They contain gases under high pressure, which means they can be extremely dangerous if not handled or stored correctly.Impr
How to Stay CSA Compliant: A Step-by-Step Guide for Commercial Drivers
The CSA program (Compliance, Safety, Accountability) is a key part of road safety in the United States. It tracks the performance of commercial drivers and trucking companies. If your score goes too high, it can lead to warnings, inspections, or even
Complaint Backlogs in Pharma: How Long Are Investigations Taking?
In the pharmaceutical industry, handling product complaints is a critical part of maintaining safety, quality, and customer trust. But in recent years, the time it takes to investigate and close these complaints has grown longer, and that’s causing s
FDA Complaint Handling Requirements Under 21 CFR Part 820.198: What You Must Document
If you manufacture medical devices, you must follow strict rules for handling complaints. These rules are explained in 21 CFR Part 820.198, which is part of the FDA’s Quality System Regulation (QSR). Failing to meet these requirements can result in s
Winter Hazards on Construction Sites: The Competent Person’s Role in Snow, Ice, and Cold Conditions
Winter brings unique dangers to construction sites. Cold weather, snow, and ice can create serious risks for workers. Slippery surfaces, frostbite, and cold stress become more common during winter months. That’s why a competent person plays a key rol