Compliance Posts

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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Combination Products: Past, Present, and Future – Part 3 of a Series

Combination Products: Past, Present, and Future – Part 3 of a Series

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

In the first two parts of this series, Combination Products: Past, Present and Future, we reviewed the historical path of combination products and the complex road to regulatory and quality compliance for this product category, leading up to today’s current state. It is important to recall that Combination Products is its own product category, independent of Medical Device, Drug, and Biologics. We discussed that fact that combination products have their own cGMP (21 CFR Part 4), but the cGMPs of the constituent parts (i.e. devices, drugs, and/or biologics) must not be neglected either.
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2018 Resolutions: Make Quality & Compliance Collective Top Priorities

2018 Resolutions: Make Quality & Compliance Collective Top Priorities

Do you ever wonder how many individuals truly commit to their New Year resolutions? How many actually follow through? The figure is difficult to calculate because more often than not, there is no system of checks and balances, no accountability for individuals’ behavior. In 2018, consider not only your own personal Quality and Compliance goals and resolutions, but engage your colleagues in sharing them with you. Be one another’s support network and ensure that those intentions are realized. Make the behaviors that support them a part of your organization’s Quality Culture for 2018.
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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 quality, compliance, and risk management. We wish you a delightful holiday season and a prosperous 2018.
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Not-So-Standard SOPs: What You Need to Know

Not-So-Standard SOPs: What You Need to Know

Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions

Formal written Standard Operating Procedures (SOPs) are required both by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why.

However, for the last couple of years, SOP deficiencies have been one of the top findings in FDA audits on both the drug and device manufacturing sides. In fact, almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs, or lack of compliance in following them, within an organization. As such, the entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects or mismanagement of the related processes.
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Pharmaceutical Organizations: Are You Ready for the Unexpected?

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Kari Miller, Regulatory and Product Management Leader, 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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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 ISO 13485:2016 Compliance – Are You Audit Ready?

The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

Sandy Carson, Marketing Manager, Pilgrim Quality Solutions

The industry continues to be buzzing about ISO 13485:2016, and with good reason. The March 1, 2019 deadline is inching ever closer and some organizations are in full preparedness mode. Some have already even conducted mock audits. Others have been granted new product approvals with the new ISO criteria already coming into focus for them. Others are simply putting team plans in place for their implementation and/or upgrade to ISO 13485:2016-ready Quality Management Software (QMS) solutions.
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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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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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