June 2019 Posts

Know Your Suppliers: Protect Your Customers

Know Your Suppliers: Protect Your Customers

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Knowing your suppliers is as important as knowing the material they provide. Life Sciences regulators around the globe could not agree more! If you have a product defect, it doesn’t matter who is at “fault”, your supplier or your own organization.

Ultimately regulators are going to hold your organization (the license holder for the finished product) responsible for the quality of the materials and services your suppliers provide you. This is evidenced in recently updated standards and regulations such as ISO 13485:2016 and EU MDR, or long-standing standards such as 21 CFR Part 820 and Part 211, or ICH Q9 and Q10. However, and more importantly, the only thing the public will see and react to is your product and your brand. It pays to maintain tight oversight of your suppliers, and not just for compliance reasons. (more…)

Achieving Customer Success with World-Class Customer Service

Achieving Customer Success with World-Class Customer Service

Charles Murphy, Cloud and Customer Success Leader, IQVIA Quality Compliance Solutions

With the advent and continuing adoption of new technologies such as cloud computing, big data, and artificial intelligence, deeper and lasting relationships at both the consumer and enterprise levels have become necessary to achieve successful business outcomes. Customer Success is the term used to describe this paradigm shift in the business world, reminiscent of the transformation last seen when IT became a value driver, in addition to a core function, within organizations.

Customer Success focuses on helping customers achieve their business objectives by optimizing the customer experience and customer satisfaction through innovative products, excellent service delivery, outstanding support, and reliable operations service levels. (more…)

Quality Management Systems: More than the Company Historian

Quality Management Systems: More than the Company Historian

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

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 is apparent that a new approach is 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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The Keys to Implementing an Inclusive Quality Management System

The Keys to Implementing an Inclusive Quality Management System

David Thomas, Sr. Director of Global Services, Pilgrim Quality Solutions, an IQVIA company

Frequently, I’m on the road speaking with customers and addressing quality professionals, and frequently I’m asked, “If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be? When implementing a quality management system, the best advice is inclusion.

It’s one simple word – inclusion – but one loaded with such wide-ranging positive impact. (more…)