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.

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to any single manufacturer, regulatory compliance is still a major challenge for companies. In fact, many of them aren’t even aware of certain regulatory risks until it’s too late.

This fact is especially true when companies use manual or paper-based methods for quality or environmental management, which make it difficult to effectively track compliance activities.

With that in mind, today’s post looks at a practical, risk-based approach manufacturers can use to identify and assess compliance gaps.

To introduce risk-based thinking across your organization ‒ as mandated in ISO 9001 and other important standards ‒ follow our Plan-Do-Check-Act checklist.

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.

While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. Clearly there are structural differences, but you may be wondering—how different are they?

Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications.

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.

Look at leading organizations with low incidence rates, and you’ll notice one thing many of them have in common: behavior based safety (BBS) programs.

BBS is a best practices strategy for improving safety performance, but without the right tools in place, companies face a high risk of failure. That’s because BBS is all about changing human habits, which are often ingrained over years of habit. You can’t manage what you don’t measure, which is why soft programs that live outside the EHS Management System often fail.

In this post, we’ll look at what BBS is and how technology can help support your BBS program, including tips on how to construct powerful BBS checklists.

Pharmaceuticals companies who want to reduce the risks of clinical trials need to realize that their document and data controls are just as important as all the ground-breaking research that goes into drug development.

Imagine a situation where your plant has a huge backlog of corrective actions 30, 60, even 90 days overdue. Defects and complaints are high, quality costs are rising and nobody seems motivated to fix the problem.

You got a nonconformance from your ISO registrar because of it, and you’ve got another audit next week where you’ll surely get hammered again. One of your most valued team members is so frustrated with the inaction and lack of accountability, he’s looking for a new job. Sound extreme?

It’s more common than you think.

Today we’re tackling the issue of overdue corrective actions, providing a practical guide for turning the ship around so you can stop this destructive cycle.

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.

EtQ has helped Maple Leaf Farms address challenges, such as allowing Quality Assurance to directly initiate Corrective Actions (CAPAs) on the Enterprise Quality Management System.