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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The Case for Cloud: Why Regulated Industries Should Pay Attention!

The Case for Cloud: Why Regulated Industries Should Pay Attention!

Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions

Cloud computing can be loosely defined as the process by which a set of data resources are housed somewhere remote and are accessed using the Internet. Traditionally, these resources have been housed inside the data owner’s own office building behind a firewall, providing very limited or no access from the outside, and thereby, protecting these resources from outside intrusion. But the pendulum is swinging again. Forty years ago it was in the form of time-share computing. Today, in the global marketplace, an increasing number of organizations are opting to move to the Cloud – which in many respects is today’s time-share computing environment, only faster, cheaper, highly secure, reliable, and more accessible.
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Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

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

Last week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
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Strategic Approaches in Integrating Quality and Risk Management

Strategic Approaches in Integrating Quality and Risk Management

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Recently, I had the opportunity to present a webinar with Thermo-Fisher Scientific, E.M.M.A. International Consulting, and The Knowledge Group addressing Strategic Approaches to Integrating Risk and Quality Management within the Life Sciences. We examined the broad subject of risk, first using a telescope, and then more closely with a spyglass, to provide both macro and micro views of quality and risk management.
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ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

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

The global economy is often the topic of blogs, articles, and macroeconomic discussions. It’s no surprise that it’s become a leading consideration in the field of Quality as well. The global economy has added complexity to our supply chains making it more important than ever to assess and control supplier risk. Lengthy supply chains make it more difficult than ever to manage suppliers and remain compliant with the plethora of regulatory requirements around the world. The updates to ISO 13485:2016 reflect this reality.
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EU-U.S. Privacy Shield Compliance: Get on Board

EU-U.S. Privacy Shield Compliance: Get on Board

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions

As we come up on the first year anniversary of EU commission adoption of EU-U.S. Privacy Shield framework, I wanted to take a few minutes to discuss Privacy Shield and its evolution. EU member states approved EU-U.S. Privacy Shield on July 8, 2016, followed by EU Commission adoption on July 12, 2016. The U.S. Department of Commerce started taking applications for EU-U.S. Privacy Shield on August 1, 2016. Since that time, over 2,000 business entities have submitted the proper registration requirements and been approved as EU-U.S. Privacy Shield certified per the published list on the Privacy Shield website.
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