LSC software closes GLP/Part 11 loophole
12 May 2006
LabLogic's Jane 4 data capture, manipulation and reporting system for liquid scintillation counters is a useful GLP/Part 11-compliant addition to the 'no frills' software supplied with most instruments.
It automatically links results from the counter to batches from LabLogics own Debra LIMS and associates all the data with the user who ran the batch. Any changes are fully audit-trailed and can be linked to an electronic signature.
This closes the loophole in most DOS-based or Windows LSC programs that makes it possible for users to create, edit or delete ASCII files generated by the counter with no audit trail of what happened.
Other features of Jane 4 include configurable archiving, which can automatically create a backup archive file when data is collected from a counter; report templates for printing or saving into Excel/csv files for importing into other applications; and email notification to the user when sample counting is finished.
Each Jane workstation can be connected to up to four counters, each of which can be a different make and model. The system manager can define the instruments by name, make and model, serial number and serial communication parameters (baud rate, stop bits, parity, etc).
A wide range of pre-configured counter formats are built into the system including models from Packard/PerkinElmer, Beckman and Wallac, as well as plate readers such as the MicroBeta and TopCount.
The contents of the output file to be created after collection of the raw data can be configured by the user, and the system manager can define any number of output formats depending on the target application (Debra, Excel, etc).
Each format is specified in terms of column delimiter (space, comma, tab), file-naming convention and the details of each sample.
The instrument may output up to 20 columns of data, such as protocol number, count time, CPM, DPM, tSIE and counter efficiency.
Configurable report templates are used at the end of a protocol collection session, and each batch in the queue can be tagged to force a report to be generated using any of the templates defined.
The output types used when adding batches to the queue can be generated by selecting a file format and report template and then specifying the output path for the data.
The Tools menu also contains the standard LabLogic dialogues for audit trail, security levels, users, and signature options.