EQMS Posts

Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Who Moved My Cheese? Address, and Conquer, the “Change Barrier” for Enterprise Quality Management

Brian Myers, Strategic Account Executive, Pilgrim Quality Solutions, an IQVIA company

The business case for quality is typically very strong, yet we still find projects mired in indecision and inaction. Spend enough time in the Quality and Compliance space working with regulated Life Sciences companies of varying size, organizational maturity, and product breadth, and you start to notice some striking similarities when it comes to reasons why really good enterprise Quality Management Systems (eQMS) projects stall or never even get started. The obvious answers are business priority, funding, and project resources. The more insidious reason is fear of, resistance to, or a complete lack of planning for an inevitable change.
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The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

Rick Lowrey, General Manager, Pilgrim Quality Solutions, an IQVIA company

Over the last year, we’ve seen an increased focus by companies on the need to transform their quality management system, and even how to extend quality management processes outside their four walls to connect their suppliers. Whether it be an enterprise Quality Management Solution (EQMS), a Supplier Management focus, or the desire to improve performance while reducing total cost of ownership by moving to cloud-based solutions, all of these themes leads to a final goal; you will need to use the power of an automated, integrated solution to improve and advance one’s quality.
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Don’t Be Shortsighted When Evaluating eQMS Solutions

Don’t Be Shortsighted When Evaluating eQMS Solutions

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

As a Sales Engineer for over a decade, I continually engage with clients through every step of the sales cycle, from the initial inquiry and Request for Information (RFI) phase, all the way beyond the selection of software solutions. Over the years, I have observed companies engage in a tremendous range of software selection strategies.

Distilling down all of those observations has revealed the one main factor that I truly believe creates a successful evaluation process, one that establishes a lasting partnership between a client and a vendor. That factor is whether a company enters into the evaluation process with a long-term vision for organizational quality versus simply conducting a point solution selection.
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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, an IQVIA company

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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Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Imperatives for Next-Generation QMS – Key Takeaways from Last Week’s Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Is your quality system keeping up with regulatory changes, industry pressures, and the demands of global business? Most quality management software (QMS) solutions on the market today are struggling to meet the rapid pace of change in the Life Sciences industry. Last week, in conjunction with PwC, Pilgrim Quality Solutions presented a webinar on the next generation of QMS.
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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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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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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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Key Takeaways from Last Week’s Complaint Management Webinar

Key Takeaways from Last Week’s Complaint Management Webinar

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Last week we hosted a webinar titled “Complaint Management Beyond Your Four Walls.” During the webinar, we discussed strategies for ensuring compliance and improving quality by automating complaint handling beyond the four walls of your organization. If you missed the presentation, you can access the on-demand version of the webinar here. In today’s blog, we’ll review some key takeaways from last week’s presentation including topics covered in the Q&A session.
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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…)