Labcompliance News, February 1999

Feb 1, 1999

New Presentation: Moving from Paper to Electronic Records

The presentation has been developed for and presented at a one day seminar at Solvay, Weesp, The Netherlands, on Jan 27, 1999: Moving from paper to electronic records, 21 CFR Part 11
The presentation covers basics of this FDA rule, most frequently asked questions, and a strategy with implementation guide for analytical laboratories.

Feb 1, 1999

New Article on Qualification of HPLC systems

The development and application of guidance on equipment qualification of analytical instruments: High performance liquid chromatography, This detailed guidance has been drafted from LGC with the assistance of the UK Instrumentation Working Group. It is published by P.Bedson and D.Rudd in Accreditation and Quality Assurance, 4 (1,2), 50-62 (1999). It is supplementary for HPLC to the general guidance on equipment qualification as developed by the same group in 1996. Besides a glossary, references and a bibliography it includes specific examples for DQ, IQ, OQ and PQ of HPLC systems. Highly recommended.