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.