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Thermo Watson LIMS is the industry standard in handling regulatory bioanalytical studies, and covers most of the important requirements from regulatory agencies.

Watson supports study archiving, but the US authorities require submission-related electronic records (study data) to be archived in a human-readable format – a requirement that Watson LIMS cannot automatically fulfill.

iStudyReporter Bioanalytics bridges this gap with a specialized Watson Study Archiving Module similar to automated submission documentation generation.

Features:

  • Cover requirements of 21 CFR Part 11 (11.10 (b) and 11.50) for Thermo Scientific™ Watson LIMS™ study data
  • Complete human-readable study data documentation in PDF/A format
  • No knowledge of Thermo Watson or iStudyReporter required for review
  • Supplementary CSV and XML file sets for further processing

For more information download the flyer.

Watson Study Archiving Module - Flyer
Events
WRIB (Workshop on Recent Issues in Bioanalysis) 2017
03.04.2017, Los Angeles, USA weiterlesen...
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