Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve all been anticipating the final electronic reporting deadline since last Valentine’s Day when the deadline of August 14, 2015 was first announced. Are you ready? For all medical device manufacturers and importers out there, don’t get stuck with a less than ideal process just to meet this deadline. Get your complimentary e-book to arm your company with knowledge you need to build a successful electronic medical device reporting process that works best for you.

Whether or not you are already submitting your medical device reports electronically, this e-book can help you understand how the process works, and design a great eMDR process to meet your mandatory reporting requirements. Learn tips from companies who were the first to implement, and get a handle on all the steps you will need to follow. (more…)

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions

For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement. (more…)

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Cost of quality, defect rates, and customer complaints can often be tied back to a common cause – poor supplier quality. Supplier-related defects are the most costly and difficult to correct, which is why managing supplier quality properly is incredibly important.

Your organization depends on you to ensure that suppliers are providing high quality materials in a timely manner. This means that you need to filter through a complex and potentially global web of suppliers, and understand where potential problems are occurring (or where they may occur in the future). So let’s take a look at some process improvements that will help you hone in on your most important suppliers and manage their quality activities for maximum impact. (more…)

4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Riddle me this: Why is an eMDR not a true electronic equivalent of a Form FDA 3500A MedWatch report?

Do you know the answer? If you don’t — that is, if you didn’t respond, or your mind went blank on this riddle — well, then you’d technically be correct. If this still isn’t making sense, you’ll understand by the end.

You see, aside from the obvious answer that one is a fillable PDF form and the other is an electronic XML file, there also are distinctions regarding the acceptable manner for leaving fields blank when you have “nothing” to answer. (more…)

Like The Three Bears: Looking for the “Just Right” Change Management Process

Like The Three Bears: Looking for the “Just Right” Change Management Process

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions 

At the table in the kitchen, there were three bowls of porridge. Goldilocks was hungry. She tasted the porridge from the first bowl.

“This porridge is too hot!” she exclaimed.

So, she tasted the porridge from the second bowl.

“This porridge is too cold,” she said

So, she tasted the last bowl of porridge.

“Ahhh, this porridge is just right,” she said happily and she ate it all up.

Everyone fondly remembers this old children’s tale. But surprisingly, this work of fiction has a place in today’s reality. If you work in a highly regulated industry, its message is directly tied to your company’s success. (more…)

Social Listening for Life Sciences: A Beginner’s Guide

Social Listening for Life Sciences: A Beginner’s Guide

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Whether we use social media for personal or professional reasons, most of us think about social media as an opportunity to express our ideas, opinions, or messages. Within most businesses, including Life Sciences organizations, social media is managed by the Marketing team. Quality and regulatory personnel don’t typically interact with social media on the organization’s behalf.

Is there something you could or should be monitoring within the constant stream of tweets, updates, likes, hashtags, and blog posts? We think so, and that’s where social listening (or social media monitoring) comes in. Social listening is the process of monitoring the Internet, including social media posts and comments, for information about your company, brand, or products. (more…)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?

Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting. (more…)

Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well. (more…)

UDI Resolutions: Ringing in the New Year with Compliance

UDI Resolutions: Ringing in the New Year with Compliance

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Every year when January rolls around, there’s a cultural shift toward new beginnings and starting the year off right. Countless articles are published about making New Year’s resolutions, and gyms are packed with athletic hopefuls. People resolve to make self-improvements, even in their daily work lives.

A new year can signify the beginning of new projects or initiatives in the workplace, too. This typically includes setting goals to be more effective, efficient and productive than the prior year. (more…)