Analytical Method Validation

Computerized system validation (CSV) has an uninspiring reputation for being a slow, no-value-added activity that only wastes time and delays the implementation of new software. Is that an accurate portrayal? And is it a necessary evil?

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.

Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.

Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.

Columnist Bob McDowall discusses operating system security patches.

Part IV of this four-part series wraps up the discussion of mass calibration, covering the "new generation" attributes that have become apparent as researchers aim to meet the calibration demands of proteomics.