Justin Smith Posts

Monitoring Supplier Performance Throughout the Product Lifecycle

Monitoring Supplier Performance Throughout the Product Lifecycle

Justin L. Smith, Product Management Director, Pilgrim Quality Solutions, an IQVIA company

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. And the latest regulations are putting more emphasis on the fact that you are responsible for the quality of your overall supply chain. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality? (more…)

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, an IQVIA company

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year 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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Best Practices for Attaining Next Generation Quality

Best Practices for Attaining Next Generation Quality

Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company

What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization? In a recent market research study conducted for Pilgrim Quality Solutions, quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape and their current QMS capabilities and needs.

This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
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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, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company

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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Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

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

Last week we hosted a webinar titled “Regulations, Risk, and Responsibilities: Closing the Gap on ISO 13485:2016 Compliance.” The webinar was presented by Dan O’Leary, President of OMBU Enterprises, and Kari Miller, Pilgrim’s Vice President of Regulatory and Product Management. If you were unable to attend the webinar, you can watch the Closing the Gaps in ISO 13485:2016 Compliance On-demand Webinar.

During the webinar, Dan presented several areas where the latest version of ISO 13485 will present significant challenges to medical device manufacturers. These areas include supplier management, complaint handling, integrating regulatory requirements into the quality system, and the way your company approaches risk.
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Training Management and SCORM: 5 Facts You Need to Know

Training Management and SCORM: 5 Facts You Need to Know

Justin Smith, Manager of Product Management, Pilgrim Quality Solutions

Do you know the facts about SCORM? SCORM stands for Shareable Content Object Reference Model. SCORM is a technical standard, but that doesn’t mean you should dismiss it as something to be handled by your IT staff. If you’re involved in employee training and competency, you should be aware of SCORM and some of its potential benefits to your training management program. (more…)

Seeing the Big Picture: Quality Metrics and the Path to Information Maturity

Seeing the Big Picture: Quality Metrics and the Path to Information Maturity

Justin L. Smith, Manager of Product Management

Let’s talk about the elephant in the room. There is an ancient eastern parable that tells the story of several men and an elephant in a dark room. Each man is asked by the king to describe the elephant to him. The man who has his hand on the trunk says the elephant is like a tree branch; the man who feels the tail says the elephant is like a rope; the man who feels a leg says the elephant is like a pillar; and the man who feels the belly says the elephant is like a wall. None of the men describe the elephant as an elephant, and so the king is led astray.

Although there are a number of insights that can be gathered from this ancient lesson, one thing is clear. With a limited picture or partial information, one can easily be misled and establish incorrect conclusions. We see this scenario of people being in the dark play out across the business world all the time. (more…)