December 2016 Posts

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 the Quality & Compliance industry. We wish you a delightful holiday season and a prosperous 2017.

Best Wishes,
Pilgrim Quality Solutions

Quality Management Systems: More than the Company Historian

Quality Management Systems: More than the Company Historian

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

Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.

In a global industry environment that is constantly evolving, it has become apparent that a new approach will be required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.
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Evaluating the Cost of Quality: It’s Simple Math

Evaluating the Cost of Quality: It’s Simple Math

Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

Every regulated organization understands the need to implement a quality system. In fact, it’s a “shall” clause for all Life Science companies to ensure they are in compliance with industry regulations.

The focus of any effective quality system is, and rightly so, all about ensuring Patient Safety. From there, as the organization matures, its people, processes and technology evolve from a compliance, to a correction, to a prevention mindset, eventually resulting in increased quality brand recognition and shareholder value.
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