GxP Lifeline Pharmaceutical Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

April 2010

Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

Kerry Potter

What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to successfully pass any inspection.

Read more


Better Innovation for Product Development and Process Improvement

Ellen Domb Joe Miller

TRIZ is a problem-solving method based on logic and data, not intuition, which accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been greatly enhanced by international researchers from 1985 to now. TRIZ is a system of creativity methods that relies on the study of the patterns of problems and solutions—if your end user customer has the problem, we call the solution process "new product/service development" and if you the solution provider have the problem, we call it "process improvement." The same TRIZ process works in both domains. More than three million patents and publications have been analyzed to discover the patterns that predict breakthrough solutions to problems.

Read more


Improving Data and Content Migration Testing: A Top Ten for Getting Data and Content Migration Testing on the Right Track

David Katzoff

Traditionally, migrations have been tested using some form of post-migration testing, often limited to sampling. While this certainly has a role for some migrations, it starts relatively late in the overall process, is labor intensive, and misses many data-level errors. These limitations particularly come into play in highly regulated companies where the required margins of error are not feasible.

This article introduces a broad set of data migration testing techniques beginning with pre-migration testing. These techniques are all well established and offer a number of benefits. After a review of these techniques, a set of "top ten" recommendations are provided for the design of an appropriate migration testing strategy.

Read more

 

Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

Quality Event Management CAPA Training
April 14-15, 2010, Boston, MA

ECA Berlin - Deviation Management and CAPA
June 1-2, 2010, Berlin, Germany

Interphex - Pharma - IT Expo
April 20-22, 2010, New York, NY

SQA Annual Meeting
April 25-30, 2010, Cincinnati, Ohio

World Conference on Quality and Improvement
May 24-26, 2010, St. Louis, MO

BARQA Annual Conference
November 2-5, 2010, Leeds, UK

View More Events

Did you know that the FDA plans to implement its Medication Safe Use Initiative in conjunction with an industry stakeholder? The Food and Drug Administration (FDA) launched its Safe Use Initiative in November 2009 to take a more proactive role in reducing the risk of patients suffering unnecessary injuries due to medication use. The chief mission of the agency's Safe Use Initiative is to build and facilitate public and private collaborations within the healthcare community through working closely with all of its stakeholders.
Read More