Quality Management Systems Posts

Listen Up! Less Complaints and More Compliance.

Listen Up! Less Complaints and More Compliance.

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Nobody likes to hear complaints. When we do, our basic human instinct is to withdraw into our shell and stop listening. Unfortunately, in Life Sciences, ignoring a complaint can be a matter of life and death. And within any industry, the most expensive defect is a complaint from your customer. For this reason, ongoing communication flow is critical.
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Get a Grip on your Data Integrity

Get a Grip on your Data Integrity

Christoph Knez, Sr. Account Executive, Pilgrim EMEA

Data Integrity is one of today’s hot topics in the Life Sciences industry. Look at the agenda of just about any industry conference, summit, or workshop event over the last two years, and you’ll notice Data Integrity has found its way into nearly every one.

If you listen carefully to attendees and others in the industry who are responsible every day for ensuring data integrity, you’ll hear how this very complex requirement creates a lot of anxiety among many companies when they examine their particular quality management processes. Their main objective is to avoid any observations by regulatory bodies resulting from data integrity issues. But why is it so complex?

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Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Better Together: How Integrated Nonconformance and CAPA Management Help You Avoid FDA 483s

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

It’s an often cited statistic. Inadequate corrective and preventive action (CAPA) processes are still the number one reason for Life Sciences FDA 483s. Every day, the FDA issues three to four CAPA-related citations. If you’re trying to avoid FDA 483s and warning letters, your first step is to develop a CAPA process that is consistent and under control. Let’s explore some ways to make your CAPA process better by teaming up key quality processes and tools for maximum impact. (more…)

Seeing the Big Picture: Quality Metrics and the Path to Information Maturity

Seeing the Big Picture: Quality Metrics and the Path to Information Maturity

Justin L. Smith, Manager of Product Management

Let’s talk about the elephant in the room. There is an ancient eastern parable that tells the story of several men and an elephant in a dark room. Each man is asked by the king to describe the elephant to him. The man who has his hand on the trunk says the elephant is like a tree branch; the man who feels the tail says the elephant is like a rope; the man who feels a leg says the elephant is like a pillar; and the man who feels the belly says the elephant is like a wall. None of the men describe the elephant as an elephant, and so the king is led astray.

Although there are a number of insights that can be gathered from this ancient lesson, one thing is clear. With a limited picture or partial information, one can easily be misled and establish incorrect conclusions. We see this scenario of people being in the dark play out across the business world all the time. (more…)

Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

The definition of Quality is widely accepted as the achievement of customer expectations through conformance to their requirements. It makes sense then, that a Quality Management System (QMS) supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction. But establishing a QMS is a tall order in our global economy where value chains are getting longer and longer.

For organizations in Life Sciences, where the ultimate end user (customer) is a patient, and regulatory compliance is mandatory in all countries the organization serves, the task can seem quite daunting. So why would anyone want to complicate it even further by implementing a global Enterprise Quality Management System? (more…)

3 QMS Considerations for Combination Products

3 QMS Considerations for Combination Products

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Combination products bridge medical devices, pharmaceuticals, and biotech products. Each of these areas has its own respective pre and post-market regulatory requirements, making combination products all the more complex to juggle while adhering to FDA requirements and guidance. (21 CFR parts 3 and 4, 210/211, 820, and 606)

I recently attended a session presented by Frank Davis, Regulatory Director, Pharmaceuticals with RCA Associates where he covered this topic extensively for a group of SmartSolve LifeScience EQMS users and Pilgrim employees. The ideas presented below are snippets from his session.

When it comes to how to position your combination product to the FDA when seeking market approval, many things to consider are common sense. Here are 3 key QMS considerations for combination products.

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Building a Long Term Quality Management Analytics Strategy

Building a Long Term Quality Management Analytics Strategy

Dan Jacob, Research Analyst, LNS Research

Manufacturers have historically struggled to generate meaningful Quality Management Analytics. With the advent of the Industrial Internet of Things (IIoT) and Big Data Analytics, it’s now more important than ever to have a long term Quality Management Analytics strategy. (more…)

How to Get Started with Quality Analytics

How to Get Started with Quality Analytics

Matthew Littlefield, President & Principal Analyst, LNS Research

There is a lot of hype when it comes to Industrial Internet of Things (IIoT) and Big Data Analytics. Many executives today see the mainstream media marketing campaigns being run by companies like IBM with Watson winning Jeopardy and are instantly interested in seeing how such a tool might be able to solve their business problems.

Although there is undisputed business value in using Big Data Analytics to enable predictive and prescriptive analytics, LNS Research sees most industrial companies are just at the earliest stages of adopting these technologies as part of IIoT pilot projects. For most companies, there is still much work to be done in gaining insights from the data already locked up in their enterprise systems.

In this post we will examine how quality executives can start getting value from the data they already have with an eye to the future, making sure the investments made today will pay dividends in a fully mature IIoT world. (more…)

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your organization faced with an unannounced FDA audit. But unannounced doesn’t mean that you need to be unprepared or out of control. Let’s take a closer look at ways you can prepare yourself, your team, your site, your quality system, and even the FDA inspector for a successful audit.

“An audit is a unique opportunity for you to tell your story. In
essence, you are communicating and demonstrating how
you run your business within the framework of your Quality
Management System.”

Konyika Nealy, VP of QA & Validation, Pilgrim Quality Solutions

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5 Quality Management Software Lessons You Can Learn from Superheroes

5 Quality Management Software Lessons You Can Learn from Superheroes

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Superheroes give us an escape from everyday life and embody qualities to which we’re supposed to aspire. Though fictional, superheroes transport us to another world and can motivate us mere mortals to be more considerate of one another. They also have the power to convince us to open up our wallets for various movies, memorabilia, or miscellaneous merchandise. But at their core, they can also teach us some great life lessons, and even some that correlate directly to quality management. Don’t believe me? Let’s take a look at 5 quality management software lessons sourced from a variety of superheroes. (more…)