Compliance Posts

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…)

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…)

Lessons Learned Integrating SAML SSO and WS-Federation for Federated Authentication

Lessons Learned Integrating SAML SSO and WS-Federation for Federated Authentication

Leo Barcenas, Sr. Software Engineer, Pilgrim Quality Solutions

Last month we published the Basics of Federated Single Sign-On (FedSSO). This article will discuss Single Sign-On for federated authentication a bit deeper and explore what we learned by implementing and integrating SmartSolve to Identity Providers (IdP).

FedSSO (Federated Single Sign-On) Background

Federated Single Sign-On is a combination of two concepts: Federated Identity and web-based Single Sign-On. Federated Identity is the ability to link different applications or services with their mutual users. It provides a way for partner services to agree on a common and shared definition about the identity of a user authorized to use a service. There is only a single credential for each user. Federated Identity provides a simpler and easier way for administrators to manage and secure users. It also makes it easier for users to manage their credentials. (more…)

5 Steps to a Compliant CAPA Process

5 Steps to a Compliant CAPA Process

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

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…)

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.

(more…)

Fusion 2016: Reflections of a First-Timer

Fusion 2016: Reflections of a First-Timer

Rick Lowrey, CEO, Pilgrim Quality Solutions

“The most successful customer conferences are contingent on active customer participation and Pilgrim team collaboration.”

#PilgrimFusion 2016 was my first customer event since joining Pilgrim Quality Solutions as CEO in May 2015.  I had the opportunity to meet many customers at once and learn and understand their experience with Pilgrim as their compliance and quality partner. Having spent years in software, I’ve attended my share of user conferences both as a user and as an employee of an enterprise software business, but this year was an entirely new experience. (more…)

How Change Management and Continuous Improvement Work Together

How Change Management and Continuous Improvement Work Together

Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions

As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to Drive Quality:

The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.

So he really talks about how continuous improvement is the key to remain successful and to keep your organization growing.

In today’s post, we’ll discuss the relationship between change management and continuous improvement. (more…)

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

(more…)

What I Learned Through Surviving an Internal Audit

What I Learned Through Surviving an Internal Audit

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

It takes a substantial amount of planning and effort to carry out an internal audit, but the outcomes can improve your processes, the performance of your department, and your outlook. As you’ll soon see, undergoing an internal audit can be a learning experience regardless of your skills or expertise within the organization.

Now, here’s a slight disclaimer: As part of a marketing department, the processes I touch and work through are not directly related to product safety or risk. However, our marketing internal audit was a necessary preparation to drive our entire organization toward our ISO 9001:2008 certification. The tips that follow are not solely relevant to marketing, or to any particular process or department, but reflect a broad overview of what I learned through participating in the audit process. (more…)

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Quality Challenges Create Waste

In a perfect world, all products are designed and manufactured to 100% of their design specifications; all people are trained and certified; and, all equipment is properly maintained and calibrated. All incoming supplies are used in the manufacturing processes, and there are zero deviations or defects. This nirvana product paradise does not exist in our world. (more…)