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Labcompliance News, November 2000

Nov 8, 2000

New Literature: Impact of Part 11 on Chromatography Data Systems

This new publication from IVT's GMP Journal answers critical questions suchs as How to define and store chromatographic rawdata for signal and spectral detectors? What are 'exact copies' of data, and what are meta data? Exactly which method and data records should be retained, especially when data have to be re-evaluated several times? How to log-on multiple users on PC controlled multi-instrument systems? 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?

Nov 8, 2000

New section on 'Method Validation' in the LabCompliance Forum

Now the Forum has four sections: Equipment/computer validation, electronic records/signatures, other compliance issues and a new section: method validation. Any visitor can ask and answer question, a user I.D. or password is not required.