SYSTEM FEATURES
The new system covers the process from experiment design to report approval, with a wide set of custom features:
Automated import of sample information from a freezer inventory system
Custom experiment setup, implementing SOP elements to reduce the need for remembering procedural details
Direct import of different types of result files from Becton Dickinson Diva software (and an easy way to add support for new file formats)
Custom data analysis, including the various calculations and compliance evaluations of SOP based acceptance criteria
Managing the variation of acceptance criteria for different SOPs and positive control batches
Managing custom report approval and signature workflows
FDA 21 CFR Part 11 compliant electronic signing of study reports
Electronic filing of signed reports; no need for paper-based records