QMS Posts

Pharmaceutical Quality in the Cloud – Key Takeaways from Last Week’s Webinar

Pharmaceutical Quality in the Cloud – Key Takeaways from Last Week’s Webinar

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Last week, we hosted a webinar called “Make the Move – Why Pharmaceutical Quality is Better in the Cloud.” During the webinar, speakers from PwC, Concerto Cloud Solutions, and Cardinal Health shared their perspectives on the changing drivers in quality, compliance, and patient safety, and how many of those challenges are best met using cloud-based quality management tools. If you missed last week’s webinar, you can view the Make the Move to the Cloud On-Demand Webinar here.
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Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

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

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
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Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

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

The definition of Quality is widely accepted as the achievement of customer expectations through conformance to their requirements. It makes sense then, that a Quality Management System (QMS) supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction. But establishing a QMS is a tall order in our global economy where value chains are getting longer and longer.

For organizations in Life Sciences, where the ultimate end user (customer) is a patient, and regulatory compliance is mandatory in all countries the organization serves, the task can seem quite daunting. So why would anyone want to complicate it even further by implementing a global Enterprise Quality Management System? (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…)

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your organization faced with an unannounced FDA audit. But unannounced doesn’t mean that you need to be unprepared or out of control. Let’s take a closer look at ways you can prepare yourself, your team, your site, your quality system, and even the FDA inspector for a successful audit.

“An audit is a unique opportunity for you to tell your story. In
essence, you are communicating and demonstrating how
you run your business within the framework of your Quality
Management System.”

Konyika Nealy, VP of QA & Validation, Pilgrim Quality Solutions

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5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

Rob Harrison, Research Analyst, LNS Research

When an organization has determined a quality process improvement imperative and resolved to take a time-sensitive course of action by harnessing technology in the form of EQMS, there are critical elements that must be considered to ensure success. These elements relate specifically to meeting the timeline demands while guaranteeing the solution delivers the correct functionality in a secure and responsive manner without compromising user adoption and potential for improvement and expansion. (more…)

5 Quality Management Software Lessons You Can Learn from Superheroes

5 Quality Management Software Lessons You Can Learn from Superheroes

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Superheroes give us an escape from everyday life and embody qualities to which we’re supposed to aspire. Though fictional, superheroes transport us to another world and can motivate us mere mortals to be more considerate of one another. They also have the power to convince us to open up our wallets for various movies, memorabilia, or miscellaneous merchandise. But at their core, they can also teach us some great life lessons, and even some that correlate directly to quality management. Don’t believe me? Let’s take a look at 5 quality management software lessons sourced from a variety of superheroes. (more…)

EQMS Implementations: A Matter of Need and Speed

EQMS Implementations: A Matter of Need and Speed

Rob Harrison, Research Analyst, LNS Research

It’s fairly obvious to anyone with their eye on industrial operations that manufacturing has increased in speed tremendously over the past few decades due to several factors like automation, increased collaboration across departments, analytics that allow greater agility and responsiveness, and others. This is true in virtually all industry verticals.

What may be less obvious to the onlooker but is no less true, is the parallel pressure that’s been placed on quality organizations to elevate their systems and processes to deliver ever-higher quality and consistency in products. Spurred on by factors like increasingly global and disparate suppliers, tightening regulations and compliance initiatives, and immediate potential for brand and reputation damage via social media, the writing is on the wall that the processes and systems of yesteryear are no longer cutting it. Today, with increasing frequency, these issues are shaping Enterprise Quality Management Software (EQMS) implementations. But aren’t these a major undertaking? Yes, mostly—but not out of pure necessity. (more…)

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Cost of quality, defect rates, and customer complaints can often be tied back to a common cause – poor supplier quality. Supplier-related defects are the most costly and difficult to correct, which is why managing supplier quality properly is incredibly important.

Your organization depends on you to ensure that suppliers are providing high quality materials in a timely manner. This means that you need to filter through a complex and potentially global web of suppliers, and understand where potential problems are occurring (or where they may occur in the future). So let’s take a look at some process improvements that will help you hone in on your most important suppliers and manage their quality activities for maximum impact. (more…)

Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)