Compliance Posts

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Pharmaceutical Organizations: Are You Ready for the Unexpected?

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

Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.

This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
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The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

Rick Lowrey, CEO, Pilgrim Quality Solutions

In recent posts, we’ve dug into the need to transform your quality management system and even how to extend quality management processes outside the four walls of your organization. Each of these themes leads to a final goal; you will need to use the power of an automated, integrated Enterprise Quality Management System (EQMS) to achieve a mature, global quality system.

Our recent infographic details some of the typical paths that organizations take to achieve the benefits of automated, global EQMS. These end goal benefits include process and data harmonization, structured organizational hierarchies, enterprise integration, extended supply chain management, and a significant reduction in overall cost of quality.

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Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

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

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
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Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in the Quality & Compliance industry. We wish you a delightful holiday season and a prosperous 2017.

Best Wishes,
Pilgrim Quality Solutions

ISO 13485:2016 Compliance: Resources to Help You Get Started

ISO 13485:2016 Compliance: Resources to Help You Get Started

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is buzzing with information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.
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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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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.
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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…)