Compliance Posts

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 racing to absorb 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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Be Aware! Security Training and Employee Engagement

Be Aware! Security Training and Employee Engagement

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions

As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

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

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than two years away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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Deviation Management and the Next Level of GMP Compliance

Deviation Management and the Next Level of GMP Compliance

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

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.
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Key Takeaways from Last Week’s Complaint Management Webinar

Key Takeaways from Last Week’s Complaint Management Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Last week we hosted a webinar titled “Complaint Management Beyond Your Four Walls.” During the webinar, we discussed strategies for ensuring compliance and improving quality by automating complaint handling beyond the four walls of your organization. If you missed the presentation, you can access the on-demand version of the webinar here. In today’s blog, we’ll review some key takeaways from last week’s presentation including topics covered in the Q&A session.
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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

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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