Electronic Medical Device Reports: eMDR Testing with CDRH (E-Book Offer)

Electronic Medical Device Reports: eMDR Testing with CDRH (E-Book Offer)

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…)

Mobile Medical Apps and EQMS: The Latest Buzz

Mobile Medical Apps and EQMS: The Latest Buzz

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

I attended my first AdvaMed MedTech Conference in early October, and it was an awesome opportunity to interact and learn from the industry. There were many things I learned about the medical device industry, but one thing that really stood out for me was a session on mobile medical apps. (more…)

5 Things Life Sciences Execs Should Know About Supplier Quality in 2014

5 Things Life Sciences Execs Should Know About Supplier Quality in 2014

Matthew Littlefield, President & Principal Analyst, LNS Research

In today’s distributed, global economy, it’s typically a competitive disadvantage to not leverage the supplier network. It opens the door to cost savings, expertise, additional production capacity, geographic reach, and more. Reliance on external parties, however, does come with a number of quality- and compliance-related risks that can really make or break a product (and company). (more…)

3 Ideas for Reducing Quality Risks

3 Ideas for Reducing Quality Risks

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Sometimes small changes make a big difference. You’re already doing the difficult work of managing your quality system to stay in compliance and keep product quality high. But there may be some areas where you can focus to further reduce quality risk. Here are 3 areas to examine if you’d like to make some quick gains toward risk reduction and continuous improvement. (more…)