Available in 21 CFR Part 11 and standard versions, both containing many features for additional flexibility, performance and ease of use
Bio-Rad Laboratories announces new software for its Bio-Plex multiplex suspension array system.
Bio-Plex Manager 4.0 Security Edition enables compliance with US FDA 21 CFR Part 11 regulations for electronic records.
It and the standard version of Bio-Plex Manager 4.0 contain many features for additional flexibility, performance and ease of use.
The new software will ship in December, 2004.
"The Bio-Plex system has become the industry standard for multiplexed analysis of proteins", observes Leonard Pulig, manager of Bio-Rad's protein function division.
"It is a fully-integrated system providing advanced control and analysis software, validation and calibration tools and the most comprehensive range of assays available.
"Now, Bio-Plex Manager 4.0 provides advanced features for regulatory compliance and functionality required by pharma customers and other demanding researchers".
Bio-Plex Manager is said to be the only software package to provide system control, system validation, calibration, data acquisition and data reduction for xMAP assays in a single application.
Bio-Plex Manager 4.0 adds useful features in data analysis and exporting, system operations tracking and providing more data and result information to customers.
Bio-Plex Manager 4.0 Security Edition: this new software provides system security and data integrity tools to help customers achieve full compliance with FDA 21 CFR Part 11 regulations.
Users must establish policies and standard operating procedures to ensure compliance with 21 CFR Part 11. Bio-Plex Manager 4.0 Security Edition accommodates six user groups with differing levels of access to the system and records: administrator, supervisor, service, clinician 1, clinician 2, and reviewer.
Access controls and authority checks are protected by identification codes and passwords.
Members of user groups (except administrator) can apply electronic signatures to files, activating the security and audit trail features needed by pharmaceutical and health screening labs.
Additionally, unsecured files such as those created in earlier versions of Bio-Plex Manager, can be imported into the Security Edition and converted into secured files.
Once a protocol or results file has been signed, any change or action automatically generates an audit trail entry, requiring a reason to be stated.
Examples of auditable actions include signing a file, changing a protocol setting, changing the standard curve regression type, flagging outliers, and performing readings.
The security environment can be turned on and off, providing flexibility for labs requiring those features only under certain circumstances.
Bio-Plex Manager 4.0: Bio-Rad has added a number of productivity-enhancing features to Bio-Plex Manager 4.0, for customers who don't opt for the Security Edition.
The new instrument operations log provides easy tracking of all instrument operations, including: start-up, warm-up, calibration, validation, wash, plate reading (with name of result file), procedures performed, result of each operation, information about the operator and identification of instrument.
Bio-Plex Manager 4.0 lets users reset the doublet discriminator (DD) gate after reading a plate, and then reanalyse the result using the new settings.
This increases confidence in the precision of assay results.
The software now accepts barcode information for sample ID or plate ID.
The user simply plugs a standard barcode reader into the computer running Bio-Plex Manager, moves the curser to the current sample ID or plate ID field and clicks on the barcode reader trigger.
Bio-Plex Manager 4.0 provides new export formats to Excel or text files, and in XML format.
This includes the option to include raw bead events for XML export.
The company also announced the release of Bio-Plex Validation Kit 4.0, providing wat it says is the most comprehensive validation testing available in the Luminex xMAP space.
The new kit tests instrument operational qualification parameters from fluidics, optics, reporter and classification aspects.
It is designed to enable users to discriminate between an assay problem and an instrument problem.
The new MCV Plate III has new labels for Classify and Reporter bead wells, with classification regions labelled A, B, C, D and E which correlate to the new classification bottle labeling.
The new Classify bead set includes bead regions in region numbers 1, 4, 40, 54 and 100. Regions 1, 4 and 40 provide the most stringent testing for instrument performance on bead classification, since they have the lowest levels of the two classification dyes.
