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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Listen Up! Less Complaints and More Compliance.

Listen Up! Less Complaints and More Compliance.

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Nobody likes to hear complaints. When we do, our basic human instinct is to withdraw into our shell and stop listening. Unfortunately, in Life Sciences, ignoring a complaint can be a matter of life and death. And within any industry, the most expensive defect is a complaint from your customer. For this reason, ongoing communication flow is critical.
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Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Recently, Pilgrim co-sponsored a webinar with LNS Research titled “Supercharge Supplier Quality Management for Competitive Advantage.” During the webinar, Dan Jacobs, LNS Research Analyst, provided many insightful data points from his recent research and made the case for focusing on and advancing supplier quality maturity.

The data is clear…and compelling. Almost every organization can achieve significant gains by improving supplier quality management processes and maturity. If you haven’t watched the webinar, you can access it here and see the data for yourself.
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Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

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

Think about your quality system. When you initially automate a quality process, you begin by determining the ideal process flow, data you wish to capture, check points to be recorded, and how information should flow between members of your team.

But what about the intersection of where a quality process ends and another business process begins? Some of these intersections may be critical checkpoints between quality and compliance processes and the rest of your business. Notifying Quality about customer complaints, updating Production with nonconformance dispositions, or providing access to documents that need to be referenced from quality records are just a few of the examples of where quality systems interacts with the rest of the business in real-time.
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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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17 Quality, Compliance, and Risk Management Resolutions for 2017

17 Quality, Compliance, and Risk Management Resolutions for 2017

A new year has begun. For most of us that means a fresh start and a brand new set of goals. But have you set your quality and compliance goals and resolutions for 2017? Whether you’re just getting started or planning the next steps in your quality maturity, Pilgrim’s quality and compliance experts are here to help you start the year off right.

In today’s post, we’ve asked our experts, “As a quality and compliance professional, what is your top resolution for 2017?” Here are some ideas that will lead you and your organization to a happy and prosperous new year.
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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

Quality Management Systems: More than the Company Historian

Quality Management Systems: More than the Company Historian

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

Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.

In a global industry environment that is constantly evolving, it has become apparent that a new approach will be required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.
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Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor.

To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
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