BWSP-21pt11 provides a comprehensive laboratory analytical package for the acquisition and analysis of data, data storage and process monitoring. It has been designed to be compatible with numerous B&W Tek instruments and includes a provision for the automatic detection of connected equipment. BWSP-21pt11 contains the elements necessary for compliance with FDA regulation 21 CFR Part 11, enabling the software to:
• Limit system access using passwords and auto timeouts
• Log user interaction with the application via audit trails
• Restrict aspects of the software through authority checks
• Allow for electronic signatures for all of the data that is stored into the integrated relational database
BWSP-21pt11 is integrated with the BWQT chemometrics package for multivariate quantitative analysis. Spectral data can be transferred to BWQT for processing, then resultant information can be displayed back in BWSP-21pt11. Selected spectra can be transferred to BWQT for analysis and continuous trending with BWQT models for reaction monitoring. A real-time trend is provided for running continuous experiments, allowing the user to observe time-dependent changes in quantitative results along with the spectrum being collected.
BWSP can store data to both the local file system and the embedded relational database. When data is stored into the database, the data is inserted into various tables with all data and metadata. When the application is run in continuous monitoring mode, spectral data associations are made between the resulting trend data and spectral data for easier coordinated lookup and retrieval. BWSP-21pt11 can easily retrieve all data that was stored into the integrated relational database, which has enhanced features over a simple file system. The database provides better search capabilities (filters) for looking up data and stores the relationships between data so that users can request data on a batch of the associated spectra, as well as conveniently access and retrieve trends and metadata.
• Integrated Relational Database: Controlled & Structured Storage for Spectral Data, Trend Data & Metadata
• Convenient Historical Data Lookup Access for All Data Relating to a Given Search
• Off-line Analysis and Online Monitoring and Trending
• Integrated Chemometrics Through BWQT
• Compliant with 21 CFR Part 11
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