Sandy Carson Posts

Document and Change Management: These Siblings Play Well Together

Document and Change Management: These Siblings Play Well Together

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions, an IQVIA company

This is the story of a beautiful family – Mr. & Mrs. Quality Management and their two children, Document Management and Change Management. Unlike many siblings that squabble daily, the Quality family kids play very well together. Their favorite playground is in the Life Sciences where they frequently collaborate to show off their teamwork and agility.

In that arena, the siblings do sometimes demonstrate distinctive personality traits as well. For instance, Document can be overwhelming, and at times, sloppy and out of control; Change is a constant force and can be difficult at times, but prefers to be in control. In those instances, they need to support each other. There’s no denying their relationship, and that they are, in fact, better together. (more…)

Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions, an IQVIA company

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous approaches to quality improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (more…)

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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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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MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
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Best Practices in Change Control: Taming the Winds of Change

Best Practices in Change Control: Taming the Winds of Change

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

We witness the impact of Change Control every day, in the most mundane places. For instance, take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But are they really better…or just different?
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I18N L10N: Keys to a Global Quality Management System

I18N L10N: Keys to a Global Quality Management System

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

What is I18N L10N? Secret code? Part of an algebraic equation? A chemical compound? No, it’s not that mysterious or complex. It simply refers to the key elements needed to support enterprises in today’s global marketplace.

I18N is industry talk for “Internationalization.” The acronym represents the first and last letters of the word – I and N – and the 18 letters in between. (more…)

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

Time waits for no one. No one is more aware of this than companies that cater to the world’s growing health care industry. These organizations walk a fine line every day between producing life-altering solutions as quickly as they can conceive of them, and doing so in full regulatory compliance and to 100-percent quality.

Life Sciences companies today are performing this balancing act between productivity and quality amid myriad growing pressures from customers, suppliers, and regulators, as their operations are having increasingly global impact. When you sprinkle risk management concerns and reputation management into the operations mix, the pressure grows even stronger. (more…)

Get Your Documents Under Control

Get Your Documents Under Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Do people ever tell you that you’re a control freak? That’s not typically a compliment, unless you work in the Quality or Compliance departments at your company. Then it’s an aspiration.

A robust Document Control process lies at the heart of a Quality Management system. Nearly every element of auditing and compliance is verified by examining documented evidence. That’s the FDA inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh and handy. (more…)

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Practices in Change Control

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Practices in Change Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But are they really better…or just different? The reality is, companies are changing their products. It doesn’t necessarily mean it’s a change for the better.

It could be that a vital ingredient is no longer readily available or is suddenly more expensive. It could be that the competition launched a smear campaign to discredit a product by claiming it’s unsafe or unhealthy. It could even be the manufacturer’s own attempt simply to make news.

Regardless, change is inevitable and impacts every business unit and process across an organization, including the Quality Management department. In fact, Change Control is a vital part of the quality manager’s job. The FDA has certain expectations of companies and, like it or not, documenting change is one of them that falls squarely on the shoulder of QA. (more…)