August 2016 Posts

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…)