Global Supplier Performance and the Regulations Driving Change

Global Supplier Performance and the Regulations Driving Change

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

Innovation within the Medical Device industry, and Life Sciences in general, continues to accelerate at an impressive clip with the introduction of groundbreaking new technologies, resulting in an increasing portfolio of medical devices. At the same time, the global healthcare industry is seeing explosive growth in the demand for those products almost as quickly as they hit the market.
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Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Is your quality system keeping up with regulatory changes, industry pressures, and the demands of global business? Most quality management software (QMS) solutions on the market today are struggling to meet the rapid pace of change in the Life Sciences industry. Last week, in conjunction with PwC, Pilgrim Quality Solutions presented a webinar on the next generation of QMS.
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Quality 4.0: Get Educated, Get Involved, and Lead!

Quality 4.0: Get Educated, Get Involved, and Lead!

Larry Ferrere, Senior Vice President, Product Strategy & Chief Marketing Officer, Pilgrim Quality Solutions

Big Data, connected products, and profound opportunities for improvement. LNS Research is helping industry prepare for the future of Quality. LNS and Pilgrim Quality Solutions recently hosted a webinar titled, “Quality 4.0: What You Should Know, How You Should Get There.” If you were unable to attend the live session, you can view the on-demand recording here.
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Compliance, Brexit, and EU MDR – A UK Perspective

Compliance, Brexit, and EU MDR – A UK Perspective

Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

In 2016, the United Kingdom surprised the world following a referendum whereby British citizens voted to exit the European Union (EU). While news of the historic event, commonly known as “Brexit,” an abbreviation for “British exit,” took many, both inside and outside the U.K., by surprise, its potential impact has global commerce and industry actively formulating strategies to minimize or avoid any resulting disruptions.
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Deploying QMS – Have it Your Way Now and in the Future

Deploying QMS – Have it Your Way Now and in the Future

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Can you predict, with certainty, how your company’s management and IT services will choose to evolve its business and its quality management solution model over the next few years? How about over the next decade? Unless you’re a soothsayer, it would be wise to adopt a platform solution today with enough flexibility to meet whatever needs and whatever challenges tomorrow may bring.
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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

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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Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Joshua Centner, Industry Solutions Manager, Pilgrim Quality Solutions

As an Industry Solutions Consultant, I interact with clients who are evaluating the features and functions of various Enterprise Quality Management Systems (EQMS). It seems there is one major factor which is overlooked time and time again. It pertains to the overall design of the EQMS, and will impact the long-term value of the solution to an organization. This critical element is whether the EQMS is a records-based system or a process-based system.
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The Supplier Qualification Framework – Assessment, Responsibility, and Control

The Supplier Qualification Framework – Assessment, Responsibility, and Control

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
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Using Agile in a Regulated Environment

Using Agile in a Regulated Environment

Stanley Curtis, Chief Technology Officer & Senior Vice President of Software Engineering, Pilgrim Quality Solutions

Recently, I was reviewing a MOOC (Massively Open Online Course) that teaches how to use Agile methodology in the development of SaaS (Software as a Service) products. This is a great scenario for the Agile SDLC (Software Development Lifecycle) since SaaS solutions typically change on a frequent basis as new features are added, or defects are fixed and released on a defined and regular schedule that fit into one or more sprints that range in length from 1-4 weeks. As there are changes, the software is updated and pushed to production to meet new or changing market requirements. If you read the textbooks about Agile, what I just described fits the Agile narrative very closely.
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EU Medical Device Regulations: Changes on the Horizon

EU Medical Device Regulations: Changes on the Horizon

Cynthia Lambert, Regulatory and Industry Specialist, Pilgrim Quality Solutions

There are significant changes on the regulatory horizon in Europe due to the publication of the new European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which were approved by the European Parliament on April 5, 2017. The industry is now subject to a three-year transition period for compliance among medical devices, and a five-year period for compliance among in vitro diagnostic (IVD) products.
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