Integration in Chromatography - BEBAC ⢠Consultancy Services for ...
Integration in Chromatography - BEBAC ⢠Consultancy Services for ...
Integration in Chromatography - BEBAC ⢠Consultancy Services for ...
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<strong>Integration</strong> <strong>in</strong> <strong>Chromatography</strong><strong>Integration</strong>•<strong>Chromatography</strong> Data System (CDS)•Important po<strong>in</strong>ts• Audit Trail?• Data transfer to LIMS?• Data <strong>for</strong>mat: Preferable not only the <strong>in</strong>tegrationparameters, but the raw peak slices are stored.• ANDI/netCDF (AIA) <strong>Chromatography</strong> Data InterchangeFormat (ASTM standard E1947-98)• Last resort: CSV (Character Separated Variables)• FDA 21 CFR Part 11 compliant (rarely; ask!)• If possible data should not be stored only at the <strong>in</strong>strument’sPC, but copied to a central location <strong>for</strong> securedbackup.• Provide the sponsor a DVD with raw data files.Workshop | Bucarest, 19 March 201331 • 32
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