

These features create full compliance with 21 CFR Part 11 requirements.
Bioprofile 400 archive#
The BioProfile Data Management System (BDM) incorporates an effective data archive and restoration system as well as adequate security features and audit trails to automatically monitor the creation, modification, and deletion of electronic records. 21 CFR Part 11 ComplianceĢ1 CFR Part 11 describes regulatory requirements governing electronic signatures and records that assure the integrity of data from an analytical instrument such as BioProfile. True interoperability reduces implementation costs and builds a fully scaleable system to accommodate your current and future bioprocessing requirements. The result is a complete, out-of-the-box, plug-and-play communication solution. Using OPC standards, data can be transmitted from any data source to any OPC-compliant application including HMI/SCADA, data historians, spreadsheets, and databases. OPC defines a common set of interfaces so that each application retrieves data in exactly the same format, regardless of the data source.

It uses Microsoft COM and DCOM technology to enable applications to exchange data on one or more computers using client server architecture. OPC is a published industrial standard for system interconnectivity that provides a standards-based infrastructure for the exchange of process control data.

Bioprofile 400 software#
The OPC Server software can be installed on the Nova Biomedical Data Manager (BDM) or on an ancillary computer. This critical data allows the controller to initiate real-time feedback control to optimize the bioprocess. Nova’s OPC Server software allows BioProfile to transfer analytical data on key chemistries to any bioreactor controlling software that is OPC compliant.

Correlation Data Automated Testing Fully-Automated TestingīioProfile Analyzers are fully automated and designed for easy use by any operator. Results obtained from BioProfile show excellent correlation with conventional techniques. BioProfile’s automated measurement provides faster, more accurate results than off-line methods. Unlike in-situ monitoring devices, BioProfile Analyzers automated calibration protocol provides precise quality control and maintains consistency of test results.
