The fundamental aim of any computerized system validation should be to define its intended use and then test it to demonstrate that it complies with specification.
United States Pharmacopeia (USP) general chapter 1058 on analytical instrument qualification (AIQ) has finally become official and was released in August 2008 in the first supplement to the USP XXXI.1 This column reviews AIQ and discusses the impact it will have in the regulated chromatography laboratory.
This column discusses the similarities and differences between the validation approaches for analytical methods for QC product analysis and bioanalysis.
The regulatory world and associated guidance documents within the pharmaceutical industry is changing rapidly. This column gives an overview of what's happened since the start of the year.
Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories.
Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.
