Compliance and Quality Management Posts

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

What do inclement weather and FDA inspection results have in common? Whether you want to believe it or not, they can both escalate from serious to disastrous fairly quickly. For anyone who’s spent significant time in the Midwest or tornado alley, it’s common knowledge that a tornado warning is more serious than a tornado watch. The truth is, the tornado alert system has quite a bit in common with FDA inspections, FDA Warning letters, and FDA form 483s. Let’s take a closer look.

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Using Automation for Software Validation

Using Automation for Software Validation

Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions

It’s time to put down your pen and paper. Stop hoarding the mounds of paper artifacts that result from manual Computer System Validation (CSV). Free up your valuable resources for other operational tasks while safeguarding the results of your CSV. All of this is possible with automated and paperless validation tools for software validation.

The FDA requires computer systems validation for any software-driven components built into medical devices, or software used to design, build, or manufacture medical devices. The same holds true for software used in the manufacturing of pharmaceuticals, biologics, or other products or components for Life Sciences. Amazingly, some companies—large and small—still perform validation manually.
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Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
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Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.

Tell the whole story about each change.

This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.
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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
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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…)

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Can you capture or even approximate the cost of quality defects? Is it possible to put a price on a true or potential product recall? For manufacturers whose products can mean the difference between life and death, the costs can be staggering. The cost to prevent quality problems? It pales in comparison. No matter the product, the cost impact can not only be in real dollars, but reputation, market momentum, and shareholder value. (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…)

5 Steps to a Compliant CAPA Process

5 Steps to a Compliant CAPA Process

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
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The Corrective and Preventive Action (CAPA) process is a requirement for compliance as well as a trigger for continuous improvement activities throughout your quality system. Complying with CAPA requirements and maintaining a reliable CAPA process is a challenge for many Life Sciences organizations. Let’s focus on 5 improvements that will help your organization create a reliable and compliant CAPA process. (more…)