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Featured Articles

July 2009

Deadlines or Dead Projects

For all medical device companies managing a project can be a nightmare. The proper planning for and management of a project can make the difference between a successful product and a financial disaster. Most projects start out with good intentions but with improper planning, the project can quickly fall behind and run over budget for a number of reasons: poor documentation, lack of documentation, scope creep, lengthy timelines, ignored timelines, employee commitment, change control and project tracking are among some of the most common experienced in the industry. In this article, we'll take a look at the each one of these examples to see the effects they can have on a project.

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"Standard Work" for Problem Solving

When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonstrate compliance?

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BARQA Annual Conference
October 28-30, 2009, Brighton, UK

GMP & FDA Compliant Quality & Doc Systems 2009
November 19-20, 2009, Munich, Germany

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Did you know that the UK's MHRA (Medicines and Healthcare Regulatory Agency) expects 98 percent of adverse event reports related to faulty or malfunctioning medical devices to be submitted by March 31, 2010? The MHRA also specifies that the event reports must be submitted in an electronic format.

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