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Featured Articles

March 2011

Dr. George Harris

Developing a Supplier Scorecard: Devising Aspects of Supplier Performance

by Dr. George L. Harris
DBA, CPM, CPCM, President, Calyptus Group

Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer works with the suppliers to evaluate shortfalls in performance and to develop corrective actions. In some rare cases, the supplier receives incentives and rewards such as being able to provide additional products or services or being designed into future products or services by the buyer. The Balanced Scorecard method has created a significant level of interest and compliance in determining how a specific organization is performing and a supplier measurement system is the underlying way to measure supply chain performance.

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John Lincoln

Product Risk Management Under ISO 14971:2007 and ICH Q9

by John E. Lincoln
J.E. Lincoln and Associates LLC

Risk Management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

All medical interventions involve some level of risk, which is acknowledged on the FDA's website and within ISO 14971:2007 standards. The goal of the responsible manufacturer is to reduce product risk and to identify/know the levels of remaining risks, which are tied—ultimately—to a user's (clinician and patient) safety.

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Quality Event Management CAPA Workshops
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Until April 19, 2011 FDA is taking comments regarding the recently issued PGx Draft Guidance. The guidance documentation was written to provide recommendations to drug manufacturers regarding how genomic information can be used during the drug development process.
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