Quality Management
Designing the most cost-effective and efficient instrument service program requires careful consideration.
How Informatics Standardization can Help Labs Achieve Quality and Ease Compliance Burdens.
Dionex Application Notes 817 and 818 describe using automated solid-phase extraction (SPE) versus liquid-liquid extraction (LLE) for the determination of oil and grease from liquid (typically water) samples to meet the requirements of EPA Method 1664.
The FDA and other regulatory agencies consider the integrity of laboratory data to be an integral part of the drug manufacturing process. Deficiencies of out-of-specification (OOS) investigations continue to be the major cause of warning letters in the pharmaceutical industry.
To appreciate the significance—or the ubiquity— of commercial tamper protection, one needn’t go any farther than the local grocery store. You, and many other consumers, probably wouldn't use a product with a broken seal. If grocery store patrons have a low tolerance for uncertainty, imagine the burden of proof facing scientific intellectual property owners in a court of law.
In order to ensure that products going into the market meet the highest standards, many manufacturing companies have a designated division that tests the quality of its material. Brian Newell heads one such division.
If standardization is such a key element to integration and the industry has been so interested in it for so long, one might ask, “Why don’t we have these standards in place?” Answer: “Because it’s really, really hard!”
Laboratory benchmarking entails comparing the quality of one lab to measures taken from a range of other laboratories, or from the standard bearers. Its the details involved in the benchmarking process, however, that can be maddening.
