How Close is Close Enough? Accuracy and Precision
December 1st 2006The accuracy and precision of results in gas chromatography and other analytical techniques are highly dependent upon the sample and its preparation, the instrumentation, accessories and operating conditions, as well as on operator skill and experience. For these reasons, accuracy and precision for a specific methodology can be expected to vary from one laboratory or operator to another. This month, we look at statistical analysis as a diagnostic tool.
Data-Handling Software for a GLP Environment: Development and Validation Requirements
December 1st 2006In a good laboratory practice (GLP) environment, data-handling software cannot be used until it is validated. This even applies to the most simple program that performs calculations or stores data. A detailed documentation of the set-up and the performance of the software - called software validation - is required. The development and validation requirements are described in this article and illustrated with a software for robustness testing (SRT), which guides the user step-by-step through the experimental set-up and interpretation of robustness tests. This software was developed in an Excel (Windows XP) environment and is used as part of method validation in laboratories that require compliance with GLP and 21 CFR Part 11. The software was subjected to software validation regulations and is compliant with electronic records and signature rules (21 CFR Part 11) as it creates, delivers and stores electronic data. The validation tests are based on the computerized system validation (CSV) -..
European headquarters' relocation
December 1st 2006Velocity11 has announced the relocation of its European headquarters to larger purpose built offices in the UK. This move reflects the company's successful product introductions and an increase in installed systems during the last 18 months.
The Benefits of Including Certified Reference Materials in a Collaborative Trial
December 1st 2006This article assesses the advantages of including certified reference materials in collaborative method validation studies in food analysis. A recently conducted collaborative trial on the determination of acrylamide in bakery and potato products is described to illustrate this.