Compliance Posts

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.
(more…)

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.
(more…)

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.
(more…)

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.
(more…)

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.
(more…)

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

Make the Move – Why Pharmaceutical Quality is Better in the Cloud

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

It’s time to make the move to the cloud. Most businesses are taking advantage of cloud-based applications, private clouds, or cloud data storage on some level. In recent years, the cloud has surged in popularity, and many business are making the move. Early adapters and small businesses view the cloud as a way to reduce IT infrastructure and resource costs, and also as a way of gaining access to technologies that might normally be reserved for larger companies.

Today, businesses are realizing increased benefits from cloud-based technologies beyond just cost savings. For the Pharmaceutical industry, many of the challenges that quality and compliance teams currently face can be simplified by deploying a quality system in the cloud. Let’s take a look at how a cloud-based quality system can propel your compliance efforts to the next level.
(more…)

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.
(more…)

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?
(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

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?
(more…)

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.
(more…)