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Labcompliance News, September 1999

Sept 1, 1999

New site with FAQ's on 21CFR Part 11

There is still a lot of uncertainty and doubt about part 11. This new sections answers most frequently asked questions.

Sept 1, 1999

Suppliers for (Certified) Reference Material

This site has been updated. Now you can find names, e-mail addresses and/or websites of more than 40 companies providing chemical standards and/or (certified) reference material for validation, calibration and/or qualification of equipment, methods etc.
for more information click here

Sept 1, 1999

New section with journals and trade magazines

This new site gives an overview on newsletters, trade magazines etc with contents related to LabCompliance topics. It also lists all articles published and papers presented by Ludwig Huber. The site is expected to expand to list key individual publications on validation&compliance.

Sept 1, 1999

The Impact of Part 11 on Chromatographic Data Systems

New presentation

Currently almost all chromatographic data systems are and will be hybrid systems, which means records are kept electronically and signatures are made on paper. In this presentation you will learn
how to log-on multiple users on PC controlled multi-instrument systems?
how to define electronic records in chromatography and how to store rawdata for signal and spectral detectors?
what are 'exact copies', or, which 'meta data' shold be stored?
exactly which method and data records should be retained, especially when data have to be re-evaluated several times?
how to bind signatures on paper with the electronic records?
what should be part of the audit trail?
how to ensure 'instant replay' of data during inspections after five and more years?
how to write user requirement and functional specifications for such systems?
how to validate hybrid chromatographic systems?

The paper has been presented by Ludwig Huber at the IVT Symposium in London on Feb 23, 2000. LabCompliance User Club members can download e-versions of the presentation.