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September 2012

Emma BarskyLen Grunbaum

Quantifying Quality for GxP Compliance

by Emma Barsky and Len Grunbaum
Regulatory Compliance and Operational Consultants

GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.

In its simplest form, the definition of "quality" is "how good something is." But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and provide little or no guidance regarding how they should be implemented?

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David Ade

Remote Audit: Out of Sight but Not Out of Mind

by David Ade
Customer Success and Reference Manager, MasterControl, Inc.

In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognize not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

Fortunately, it is now possible to conduct an audit without being physically present at the facility under audit. The development of web-based systems, video conferencing and desktop share technology allows auditors to see information from virtually anywhere in the world.

This practice has many names: virtual audit, online audit, desktop audit, or remote audit. For this article, let us call it 'remote audit'. The purpose remains the same: the auditor and the auditee do not have to be at the same location. With remote audit, an auditee can be 'out of sight', but not out of the auditor's mind. In fact, conducting remote audits is proving to be a viable option for companies that not only need to comply with regulations, but also need to reduce the cost of the audit process.

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Cindy Fazzi

How to Build a Strong Supply Chain Team

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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Did you know that drug spending will rebound by 2016? According to a recent article: "A new report forecasts an uptick in spending for medicines over the next five years, with annual growth rising from 3%-4% this year to 5%-7% by 2016, when total spending is projected to reach almost $1.2 trillion."
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