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

 

About Pilgrim

Pilgrim pioneered quality management software more than 20 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities. Since then, our comprehensive and highly-integrated, closed-loop enterprise solutions have attracted hundreds of customers across life sciences and other manufacturing industries. Our knowledge of the global quality compliance requirements that govern the life sciences industry and the support we provide customers in the midst of an audit leads the market and has significant appeal to firms in and serving the life sciences market.

We are ISO 9001:2015 Quality Management System certified. Pilgrim is one of only a few quality management solution providers in the world whose internal processes and software development operation have been rigorously audited and certified. We are particularly proud of this achievement and distinction – and each release of our solutions and platform are validated as well.

Pilgrim has partnered with the world’s leading companies to enhance their global enterprise quality management operations and help them achieve operational and regulatory success. If you are looking for a partner who is committed to helping you deliver the highest quality products without adding complexity, look to Pilgrim.

With Pilgrim Quality Solutions as your partner, your quality platform, and the solutions you rely on for quality and compliance, you can focus on progress, not problems. Opportunities, not obstacles.
 

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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