Quality Management

Problem: Researchers and scientists generate and collect vast amounts of data in their work, whether they are running experiments in the lab or surveying and interviewing people on the street. Researchers typically don’t deal with their research outputs until towards the end of the research cycle, when poor organization and data management can be difficult to manage and address, but causes the most problems. Poor data management results in experiments that are harder to replicate and findings that may be called into question. Papers can be retracted, careers impacted and ultimately science can suffer. When researchers move on they may pass their work to others in their research group, where poor data management results in the group inheriting indecipherable written notes they cannot use.

We’ve already seen less-than-savory practices from a few scientists recently due to the tough funding environment in research these days, whether that’s altering research findings or faking them altogether for more impressive results. In the latest example of such unethical behavior, two professors from the University of Houston have been charged with wire fraud and making false statements in order to get $1.3 million in research grants from the U.S. government, according to the Houston Chronicle.

Thermo Fisher Scientific has developed a reproducible and accurate ion chromatography (IC) method for determining monochloroacetic acid (MCAA) in carbocisteine drug substance and two carbocisteine drug products, thus enabling efficient quality control of the carbocisteine manufacturing process.

Every laboratory manager and company executive has had these thoughts at some point: “Another regulation. OMG. What do they want now? Will the government ever leave us alone? How am I ever going to get anything done?”

Laboratory informatics tools are used in laboratory environments across the world that directly touch the everyday human experience. The rapid pace of change in the area of laboratory informatics over the last six years has led to a significant revision of ASTM E1578, Guide for Laboratory Informatics.












