March 2013

For Medical Device Companies

Featured Articles

Walt Murray

Surviving the Hosted Compliance Audit: Front Line, Back Room and in the Shop

by Walt Murray
Director of Quality and Compliance Services, MasterControl, Inc.

Compliance audits present their own orientation to an organization that wants to present the perfect front while being asked to air their dirty laundry. Is this inspection about smoke and mirrors or does the audited facility present a "zipped-tight" posture toward the investigator?

The answer to approaching such a situation involves scenario planning and a true understanding of the company's regulatory weak links during a compliance visit. Somehow, the investigator has a bloodhound sixth sense about "poking" around during an investigation visit. The job of an investigator is to find the weak links and 'holes' in the approach of an organization as to how the regulation is a part of the fabric of a company. On the day of the audit, there are some key factors needing consideration to successfully host a compliance investigator.

First, the company's key representative should obtain a business card from the investigator upon arrival and ask him to be seated for a moment to allow for the initial "mobilization effort" to occur. This phase is important because the standard operating procedure (SOP) for hosting such an event should "go live" at this point. This is not a drill! The company representative should be a person familiar with the local compliance office staff who is comfortable helping the compliance officer perform the investigation. Simultaneously, the company's "lieutenant" or second in command should be sure that the room of residence for the investigator is ready.

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Jim Cook

Business Benefits of Archiving

by Jim Cook
CEO, Arkivum

The word “archive” is springing up all over the world of IT and data management. Why now, and what are the implications to an organization working within the highly regulated world of a GxP environment? This article sets out some of the key business drivers around long-term data storage, and offers some lifelines to IT professionals drowning under a deluge of data.

In a recent report , McKinsey projects a 40% growth in global data generated per year, while growth in global IT spending will manage only 5% each year. Against that backdrop McKinsey believes that the value of making use of big data to the U.S. healthcare market could be $300 billion, more than double the total annual healthcare spending in Spain.

So we know that data growth is enormous, that IT budgets will be hard pushed to cope, and yet there are huge benefits to those that are able to successfully ride this roller coaster.

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