Whole Body Section software at autoradiography meeting

8 May 2006

LabLogic Systems will be demonstrating its Seescan software at the next European Society of Autoradiography meeting (14 - 17th May, Basel, Switzerland).

The intuitive, user-friendly and comprehensive methodology of the program has made it an industry standard for the performance of Whole Body Section (WBS) autoradiography analysis under GLP conditions.

Seescan runs independently of Windows platform and supports imaging file formats from all standard scanners including, Molecular Dynamics, Fuji, Biospace, and Cyclone Phosphor Imaging Systems.

Measurements can be taken by framing the region of interest with a variety of drawing tools, including circular, rectangular or user-drawn frames of variable size.

Selected areas can be defined by using grey level thresholds. The image may also be zoomed and contrast enhanced to allow accurate analysis of small or poorly defined tissues.

For each measurement, the region area, the raw/calibrated result and the measurement reliability (% error) are stored.

Results can either be displayed individually or as a mean for the tissue being measured. Individual results can be cross-referenced with the region they were obtained from by simply clicking on the measurement - the image appears with the measured region highlighted. All data can be reviewed and transferred to other Microsoft Office applications.

Seescan operates as a GLP-compliant, password-controlled system with a comprehensive audit trail and the option to use electronic signatures.

The system manager has the ability to access all studies, set up and delete users, and restrict access to studies and

software. Only users defined in the protocol have access to the study.

All data entered, including the protocol, are time-, date-, and user-stamped. If any data is altered or excluded the user is forced to enter a reason, which is stored with the data in the study audit trail. All data for each study is stored in an encoded study file.

To start a study, the user defines the protocol. This provides an experimental description, defines whether the study is to be GLP-compliant and defines whether the data is to be calibrated. Before starting the measurements, the user can either complete the study protocol by entering the sections and tissues to be measured, or by inputting them during the course of analysis.

If the study images contain calibration standards, raw measurements can be converted into calibrated units. For each standard, the user measures and enters its nominal value. The calibration curve is calculated and displayed.

Calibration algorithms include linear, quadratic, cubic, log/linear and sigmoidal. The best fit to the curve may be obtained using the different calibration algorithms. Suspect data points may be excluded from the curve but remain visible on the graph.

A variety of image display functions are provided, including normal, image inversion, contrast enhancing and pseudo-colouring. The software also allows four images to be montaged using the same pseudo-colour scale for comparison.

Seescan has a comprehensive and flexible security structure to control access to menu items and form-level functions and to guard against unauthorized access to data - essential in a regulatory environment.

The program is able to integrate with LabLogic's Debra ADME LIMS, allowing users to perform the study protocol definition within the LIMS and export it to Seescan.

Following analysis of the data, the resulting information can be seamlessly transferred back to the Debra study database, ensuring data integrity and preventing errors.

Security is also shared so that user names and passwords are linked in both systems.

Seescan is designed to fully support GLP and associated regulatory requirements and specifications for both laboratory operations and laboratory software design.

This includes functionality to meet with the FDA 21 CFR Part 11 ruling for electronic signatures and electronic records.

The system allows for System Manager control of signature points on key events. Each area of the application that could require a signature is configurable.

Administrators can disable the signatures, set a silent signature which doesn't require any action on the user's part, and set a single signature or two signatures (the second signature normally being approval of the first).

Signed electronic records contain information associated with the signing that clearly indicate the printed name of the signer; the date and time when the signature was executed;

and the meaning (such as review, approval, responsibility, or authorship) associated with the signature.

Like all LabLogic's products and services, Seescan is covered by the company's ISO 9001 accreditation, which it has held continuously since 1998.

This encompasses design, development and supply of laboratory information management systems; and scientific applications software with ongoing maintenance support,

including the supply of instrumentation systems for pharmaceutical, agrochemical and contract research organisations.

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