Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating within compliance.

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.

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.

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?

Wrong.

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.

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.

The ECA Academy shared that in 2016, most GMP inspection deficiencies involved quality systems—more specifically, the Corrective and Preventive Action (CAPA) process.

A closer look revealed that root cause analysis and impact assessment are still a challenge for many organizations. These organizations struggle with taking measures to prevent recurrence of adverse events.

A possible explanation for this challenge is that organizations are not leveraging leading and lagging indicators to their advantage when building corrective action management processes.

Learning to understand leading and lagging metrics and how to use them in your organization can be a gamechanger in the Life Sciences.

Improving waste management is a top priority for many companies in the EHS industry.

As environmental initiatives gain momentum across many sectors, organizations are pushing to not only comply with hazardous waste regulations but exceed them.

Waste management tools give you oversight of all waste activities, storage areas and shipments to keep waste goals and targets top of mind.

Here are some of the ways utilizing EHSQ software streamlines waste management efforts.

Under the Toxic Substances Control Act, the EPA is given the authority to issue regulations regarding the exposure to, testing of and controlling of chemical substances. To keep the workforce and environment safe, regulators have created globally recognized standards for classification and labeling of hazardous chemicals as well as REACH for the European Union.

These standards require an ongoing effort to manage chemical inventory and workplace safety.  Automated EHS software has tools to help you maintain chemical compliance efficiently and safely.

Water and wastewater management are closely tied with energy use, environmental impact and employee safety, as each of these impacts—and is impacted by—water management processes in your organization.

Just like with all of your other EHS processes, how you manage and organize water and wastewater management can make a big difference in its success.

Here are some benefits of managing all water and wastewater permits, analytical results and reports in one central platform.

Technology, business best practices and quality management all saw substantial growth and change in 2017. We don’t anticipate that these areas will stop innovating any time soon.

We talked to five of our industry leaders to find out what quality management trends we’re likely to see in 2018—with focuses on the market outlook, the evolution of technology, regulated industries, Environmental Health and Safety (EHS) and software.

ISO standards are the backbone of quality management. They set detailed criteria for best practices for quality management processes and systems.

Learning the best ways to apply these standards to your operations is extremely important for compliance success. Executing ISO standards with the proper tools lets you efficiently master compliance.

Of those tools, document control is one of the most critical because it standardizes your documentation and training processes and mitigates risk.

Document control aligns with the goals of ISO standards to achieve and maintain compliance.