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…)

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

Matthew Littlefield, President & Principal Analyst, LNS Research

Nearly every executive responsible for quality and compliance in life sciences has the topic of culture on their mind. Why? Because in an industry driven by innovation, deep down it’s the people — the scientists, the engineers, the shop floor workers — that separate one company from another. And having a culture that puts quality and compliance first can be the foremost source of differentiation.

Although many executives understand the importance of a quality and compliance-based culture, few have actually been successful in developing their own. Our recent Quality Management Systems survey verifies this, revealing that 30% of life sciences executives feel their organization considers quality much more of a single department rather than an organizational responsibility. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)

Life Sciences Quality Challenges: EQMS Webinar Follow‑up and Infographic

Life Sciences Quality Challenges: EQMS Webinar Follow‑up and Infographic

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

LNS Research recently hosted a webinar highlighting steps to help Life Sciences firms address quality challenges. The webinar presented three quality-related initiatives that have delivered measurable business results. Each concept is outlined below, followed by the infographic that summarizes the findings from LNS’ research. (more…)