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DID YOU KNOW...

That a streamlined IT system could increase end-to-end trial visibility and accelerate clinical trials by 10 percent or more?
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Especially for Pharmaceuticals

One of the main topics discussed at DIA?s 43rd annual conference was the FDA?s format requirement for new electronic submissions. Read about what was discussed?
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Especially for Pharmaceuticals


Especially for Medical Devices

FDA is temporarily postponing the annual registration of registered medical device companies. The government agency is planning to make some changes to improve efficiency for everyone involved.
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Especially for Medical Devices



Especially for Blood / Biologics

The Food and Drug Administration (FDA) requires that blood establishments face some of the toughest regulations and standards today to ensure the safety of the blood supply. Electronic document systems are quickly becoming an integral part of quality systems at blood banks and transfusion centers across the United States in an effort to keep the blood supply safe and clean.
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Benefits of a Risk-Based Approach
By David Ade

Of the 242 medical devices recalled by the U.S. Food and Drug Administration (FDA) between 1992 and 1998 for reasons related to software failures, “192 (79 percent) were attributable to changes made to the software after its initial implementation.” If software solutions are not deployed and validated properly the results can be product recalls, production downtime, business closure, or—worst case scenario—risk to patients’ health. Using a risk-based approach to validate software allows life science companies to save effort, time, and money, without affecting the quality and safety of the software. Avoiding software validation pitfalls begins with evaluating potential risks and developing a plan to deal with hazards once they have been identified.

Life science industry analysts, validation experts, software solution vendors, and the FDA are all calling for the industry-wide adoption of a risk-based approach to validation. To understand why, one must first examine how the risk-based approach is defined. The “21 CFR Part 11 Electronic Records, Electronic Signatures, Scope and Applications” industry guidance recommends that software validation be focused on “a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.” Based on this “justified and documented risk assessment” companies can evaluate the best approach to validating the system and determine how much testing is necessary. According to the General Principles of Software Validation guidance, the “selection of validation activities, tasks, and work items should be commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use.”
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Project Management in a Learning Organization: Thriving on Change While Delivering Results

Life science industries are no different than any other money-making organization: their bottom line is profit. The difference in their profitability, though, often lies in the way they conduct their business.

Peter Senge of the Massachusetts Institute of Technology advanced the theory of the learning organization. He said learning organizations are “…organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together.”

Why is a learning organization important in today’s technological society? Because the level of performance and improvement in today’s business climate requires extensive learning and training. In industry, health care, and government, there is no clear path to success, so employees need to explore new ways to think about problems.

The rationale for learning organizations is that in situations of rapid change, only flexible, adaptive, and productive organizations will flourish. Leaders will use technology to advance the organization and project teams will be encouraged to think in new ways and use new tools to solve problems.
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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

IVT Pharma Technology Conference

(Aug. 24-26, 2007)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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