Life Sciences Posts

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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Eliminate the Validation Bottleneck

Eliminate the Validation Bottleneck

LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LNS Research.

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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…)

7 Challenges of Managing Change (and How to Deal with Them)

7 Challenges of Managing Change (and How to Deal with Them)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Only so much fits into a 40-hour work week. Pressing deadlines, critical projects, and a growing list of priorities can make it difficult to complete everything that needs to get done. Introducing changes adds new layers of complexity to the mix.

But fear not, managing change throughout your organization does not need to be stressful. Having the right processes and tools can help. Let’s take a look at some of the top challenges and how to beat them. (more…)

I18N L10N: Keys to a Global Quality Management System

I18N L10N: Keys to a Global Quality Management System

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

What is I18N L10N? Secret code? Part of an algebraic equation? A chemical compound? No, it’s not that mysterious or complex. It simply refers to the key elements needed to support enterprises in today’s global marketplace.

I18N is industry talk for “Internationalization.” The acronym represents the first and last letters of the word – I and N – and the 18 letters in between. (more…)

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Matthew Littlefield, President and Principal Analyst, LNS Research

The demands on quality organizations are rising across the board, but perhaps none as quickly or urgently as in the life sciences industries. While increased competition and the need to innovate certainly aren’t unique circumstances for life sciences, the level of scrutiny from regulatory agencies and the rapidly evolving nature of the supplier network are, placing an incredible burden on elevating supplier quality management capabilities. (more…)

8 Sites Life Sciences Quality Managers Should Follow

8 Sites Life Sciences Quality Managers Should Follow

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to keeping your ears tuned to the latest industry news, there are so many resources and voices vying for your attention. It can be tough for Quality Managers to know which sources to really keep an eye on, which to bookmark when you need to research or gather information on a particular topic, or where to go for commentary on industry hot buttons. Here we’ve gathered a list of resources you should browse, bookmark, or tune in to help keep you informed. In no particular order, here are 8 resources and one bonus site to peruse. (more…)

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…)

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…)

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

There’s a popular saying: ‘You don’t know what you don’t know.’ No kidding. But nowhere is this truer than in the regulated workplace. When employees aren’t trained, they run the risk of adversely impacting its quality, its compliance, its reputation, even its profits.

That’s why employee training is an essential component of a comprehensive quality management system. In fact, you’re likely to find well-trained employees at the foundation of any successful organization that manufactures safe, dependable, quality products. (more…)