March 2013

For Pharmaceutical 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.

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Peter Knauer

Correcting and Detecting CAPA Horrors

by Peter Knauer
Partner Consultant, MasterControl Inc.

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration's (FDA) Quality System Regulations---and specifically 21 CRF 820.100 and ICH Q10---implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems. This, unfortunately, is not always the case. I am currently spending a lot of time working with client companies in remediation mode; that is, after FDA has found enough flaws to issue a 483 or warning letter. I would like to point out some common CAPA problems that can be proactively rectified to avoid citations in the first place.

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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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EduQuest Surveys CAPA Progress in Past Six Years

by Martin Heavner
Director, Marketing and New Products, Eduquest

Denise Dion, VP of Regulatory & Quality Services at EduQuest, and Compliance-Alliance are updating a landmark CAPA Benchmarking survey done for the FDA in 2007. The goal is to determine how device-makers are implementing the CAPA requirements under FDA's Quality System Regulation.

If you'd like your voice heard, access the survey with this link: http://www.surveymonkey.com/s/QQRB2BG

The survey contains 28 questions and takes approximately 10 minutes to complete. Your individual responses are completely anonymous.

To see the results of the 2007 CAPA survey, visit this link (no registration or download required): http://www.surveymonkey.com/sr.aspx?sm=nMJVIlm_2fKHoc_2fW5_2bMi4A099HFos09c5eVRzWx3og90k_3d

For further information, contact Martin Heavner through LinkedIn or MartinHeavner@EduQuest.net.

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