EQMS 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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I18N L10N: Keys to a Global Quality Management System

I18N L10N: Keys to a Global Quality Management System

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

What is I18N L10N? Secret code? Part of an algebraic equation? A chemical compound? No, it’s not that mysterious or complex. It simply refers to the key elements needed to support enterprises in today’s global marketplace.

I18N is industry talk for “Internationalization.” The acronym represents the first and last letters of the word – I and N – and the 18 letters in between. (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.

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EQMS Implementations: A Matter of Need and Speed

EQMS Implementations: A Matter of Need and Speed

Rob Harrison, Research Analyst, LNS Research

It’s fairly obvious to anyone with their eye on industrial operations that manufacturing has increased in speed tremendously over the past few decades due to several factors like automation, increased collaboration across departments, analytics that allow greater agility and responsiveness, and others. This is true in virtually all industry verticals.

What may be less obvious to the onlooker but is no less true, is the parallel pressure that’s been placed on quality organizations to elevate their systems and processes to deliver ever-higher quality and consistency in products. Spurred on by factors like increasingly global and disparate suppliers, tightening regulations and compliance initiatives, and immediate potential for brand and reputation damage via social media, the writing is on the wall that the processes and systems of yesteryear are no longer cutting it. Today, with increasing frequency, these issues are shaping Enterprise Quality Management Software (EQMS) implementations. But aren’t these a major undertaking? Yes, mostly—but not out of pure necessity. (more…)

Life Sciences Quality Challenges: EQMS Webinar Follow-up and Infographic

Life Sciences Quality Challenges: EQMS Webinar Follow-up and Infographic

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

LNS Research recently hosted a webinar highlighting steps to help Life Sciences firms address quality challenges. The webinar presented three quality-related initiatives that have delivered measurable business results. Each concept is outlined below, followed by the infographic that summarizes the findings from LNS’ research. (more…)

When Does it Make Sense to Automate EQMS?

When Does it Make Sense to Automate EQMS?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

You need to manage your quality system, and you might think you have everything under control with a manual process. But manual processes including disparate tracking systems for controlling documents, deviations, customer complaints, change controls, and other quality processes are often cumbersome and difficult to control, with limited to no visibility across processes.

So when is it necessary to bite the bullet and adopt an automated enterprise quality management system (EQMS)? The timing may not be the same for every organization, but you should examine your quality management processes and see where quality management software can help fill in the gaps, creating a more cohesive closed-loop process and better preparing you for any internal audits, regulatory inspections, or regulatory reporting. (more…)