Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

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.
(more…)

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?

(more…)

3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

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

3D printing or Additive Manufacturing is the new frontier in the Life Sciences industry and personalized medicine, where medical devices and even pharmaceuticals can be produced on demand, with specifications suited to a specific patient. For the Life Sciences industry, it means the potential to transform the way patients are treated, improving the efficacy of their treatment and their quality of life.
(more…)

MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

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

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
(more…)

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.

(more…)

ISO 13485:2016: Are you prepared for the transition?

ISO 13485:2016: Are you prepared for the transition?

Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.

Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.

Checkpoint 1: Has your organization kept pace with regulatory requirements?

If you’ve been keeping pace with evolving regulatory requirements, your organization will have a simpler path to ISO 13485:2016 compliance. It depends on whether your organization is aligned with internationally converging quality regulations and guidances, as well as the maturity of your existing quality system.
(more…)

Identity and Access Management in Quality and Compliance

Identity and Access Management in Quality and Compliance

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

Identity and Access Management (IAM) has become a necessary part of enterprise IT and the security infrastructure of an organization. While mostly driven by security concerns, IAM also makes life simpler for the end user of enterprise applications. This is particularly true in today’s world of tight integration between disparate enterprise software and the continuing increase in the adoption of ‘Best of Breed’ SaaS applications. (more…)

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…)