Traditional business methods are enough to handle basic manufacturing processes but can’t keep up with the pace at which markets and technology are advancing.Read More
If you’re just getting started as a quality professional, it can be overwhelming. If you’re unfamiliar with the industry, it’s hard to even know where to find guidance.
To help you get started, we’ve put together some of the best quality and compliance resources we know.Read More
Training your employees should be more than just having them memorize processes and testing them on safety procedures. The latest developments in EHS training software for employees revolve around engagement and utilizing today’s latest technology. Tools like mobile devices and virtual reality have completely changed how managers can create effective and engaging safety training programs.
Here are some of the upcoming trends for EHS Management Software training that leaders should be paying attention to:Read More
On April 3, 2018, the United States Food and Drug Administration (FDA) issued its first ever mandatory recall to Triangle Pharmanaturals for kratom that was contaminated with salmonella.Read More
Environmental, health and safety (EHS) management has always had three main goals: to keep people safe, minimize negative impact on the environment and keep operations running productively and without incident. This means adhering strictly to compliance regulations and looking for new ways to increase profitability while decreasing incident rates.Read More
Previously, audits meant surprise business interruptions for manufacturers and a lot of travel and administrative work for auditors. With many Life Science manufacturers operating internationally, they were being audited separately to satisfy the requirements of each country in which they operated. At the end of the day, there was a lot of repeat work on both ends.
So regulatory agencies and legislators have come together to develop single audit programs that create comprehensive audits that satisfy the requirements of multiple countries. This creates a globally harmonized and efficient international audit management system.
One of the major programs is the Medical Device Single Audit Program (MDSAP). As the deadlines for these changes approaches quickly, here are 3 things that medical device manufacturers should know about the MDSAP.Read More
Six people were killed in the collapse of a pedestrian bridge at Florida International University on March 15.
The bridge, designed to keep students safe, did just the opposite in its final stages of construction. A National Transportation Safety Board team is launching an investigation to determine exactly what went wrong.Read More
You have a solid quality system in place for product design, production and testing. Your medical devices pass all tests with flying colors. You’re off the hook once they leave for distribution, right?
Quality management extends beyond your four walls. If a product has your name associated with it, it’s your responsibility even once it’s in the hands of patients.
Here are four ways to effectively manage postmarket events with automated Quality Management System (QMS) software.Read More
Emergency Preparedness Plans (EPPs) let you record personnel, equipment and external parties associated with emergency procedures.
This document is equally as important to members of the EHS and emergency response teams that must create it, as it is to other employees of the organization that must follow it.
Here are three steps to utilize your EHS software to build an effective EPP.Read More