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Featured Articles

June 2011

Jon Nugent

How to Build a Business Case for a Quality Management System

by Jon Nugent
Managing Director of Client Services, Business Intelligence Solutions

It is impossible for FDA regulated manufacturers to conduct business without paying close attention to regulatory compliance.

FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. Also, complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. This expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

Investing in a scalable, enterprise compliance solution can have significant top-line and bottom-line benefits that extend well beyond simply achieving compliance.

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Writing and Enforcing Your SOPs for GxP Compliance Success

by David R. Dills
Quality & Compliance Advisor

"Say what you do, do what you say, and be able to prove it."

This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements.

Typical definitions include "the procedures and processes that you use and operate under and that have been standardized to ensure they are done the same way each time" or a "clearly written description of how specific tasks are to be done." Or, another definition is "detailed written instructions to achieve the uniformity of the performance of a specific function."

If you are a medical device or a pharmaceutical manufacturer, these definitions are no surprise when it comes to FDA regulations because 'establish' means define, document (in writing or electronically) and implement. The goal and emphasis with FDA is simple.

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Quality Event Management CAPA Workshops
June - October 2011, Various Locations

RAPS Annual Conference and Exhibition
October 23-26, 2011, Indianapolis, IN

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"For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on," Commissioner of Food and Drugs, Margaret Hamburg, explained in her opening address at FDLI's 54th Annual Conference.
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