Version Debra™ 5 -Industry Standard Protocol based LIMS

Debra has been designed from the ground up to handle the complexities of modern protocols. The full range of ADME studies are easily handled from Mass Balance, Tissue Distribution, PK and any combinations. With the Protein Binding module, a full of suite of protein binding assays can also be performed within Debra. The pooling module and dynamic link with our Laura radiochromatography software facilitate metabolite identification and quantification.

To achieve the goals of high productivity and GLP confidence, Debra captures raw data either directly from the instrument or via sample result data files from analytical instrumentation systems, and performs all calculations. This automatic data capture is used throughout Debra, from dose solution preparation and administration through to sample collection, completely eliminating transcription and calculation errors.

All data and results can be reported via Debra`s reporting package. Our unique Document Management System seamlessly integrates tables, graphs and text into final report templates through an automated link to Microsoft Word.

• `THE INDUSTRY STANDARD`
• Study based ADME/Protein binding specific LIMS
• Oracle Client/Server architecture
• Full FDA/GLP compliance complete control

Protocol/Study Design 
Modern protocols are increasingly complex. Debra has been designed from the ground up to handle this complexity. The full range of ADME studies are easily handled including Mass Balance, Tissue Distribution, PK and any combination of the above. Unlike LIMS that are essentially QC tracking systems with a protocol module added on, Debra is designed to facilitate the achievement of study objectives.

When a study is created, the default configuration values associated with its related project will be applied to the study to achieve consistency while maintaining maximum flexibility. This will also allow for the creation of cross-study analysis reports.

Once a study has been accepted, Debra will provide an audit trail detailing changes made to the study. Deviations and amendments are tracked for each study.

Dosing Module 
The interactive Dosing Module gives the facility for the interactive weighing and dosing of the subjects. Dosing and Treatment Modules are linked to provide data on the specific activity of the treatment being dosed. The link allows the system to check dosing volumes/weights and calculate the amount of activity administered.

There are several methods from which to choose covering the variety of options currently used in the metabolism laboratory. Multi-dose studies using multiple dose preparations are catered for. The user can record the actual time of dose and any associated comments/observations. The recorded time of dose can be used within the system to calculate real-time sampling for PK studies.

As with all Debra`s modules the system comes complete with full GLP audit facilities, is fully FDA 21 CFR Part 11 compliant and links to laboratory instrumentation for the direct capture of all raw data.

Labelling Module 
Tired of printing out labels for your study on a separate package? The labelling module of Debra allows the user to generate project specific labels in any number of user-defined formats based on the project data entered into the system.

Both the label type/size and the content are defined by the user, making it a flexible and powerful tool. Pre-defined label formats can be set to cover the corporate standard. Adding barcodes to the labels will allow the user to take advantage of bar-coding options for data collection, that not only speeds up the processes within the laboratory, but also reduces the risk of user error.

WBA Module 
The WBA module can enhance the performance of the metabolism laboratory by utilizing common features used routinely in ADME studies within the Debra package. The use of the project driven treatment, dosing and reporting functions allows QWBA to exist as part of a larger ADME study, or as a discrete project. Within Debra, QWBA reports can also be saved to the Document Management System for seamless reporting in a secure environment.

Reporting and Document Management System 
The reporting package provides exceptional convenience and flexibility. Define columns, print order, assign macros, add free text, size the table and its position and even specify the decimal precision of the data.

All reports generated in Debra may be saved to the database using Debra`s Document Management System. This is a unique system that seamlessly provides for the integration of tables, graphs and text into final reports through an automated link to Microsoft® Word. Debra records the document history, highlighting changes between versions of the document. As such, the assembly of critical pieces of information, through standard templates linked to study-specific reports, quickly and accurately facilitates the creation of final reports.

Links to Laura 
A link to our industry-standard radio-chromatography software is now available. This permits two-way exchange of data between Laura and Debra. For example, projects and sample data can be created in Debra and subsequently imported into Laura. In addition, chromatograms and region table data from Laura are available for further analysis and reporting in Debra. Security for both systems can be linked, so that users can have one username and password for access to Laura and Debra.

Splitting and Pooling 
Samples may be split and pooled within Debra to create additional samples for further analysis. Samples may be pooled by dose group, gender or by timepoint. Debra can calculate a percentage amount to be split, and calculate which samples need to be pooled based on percentage recovery of the dose. The user may choose to use theoretical weights and counts for the pooled samples or you can capture all the data online using Debra`s weight and LSC batch functions.

Protein Binding 
Protein binding assays, including blood cell partitioning, equilibrium dialysis, ultracentrifugtaion and ultrafiltration, can be performed. Debra accommodates the full process, from assay design to stock solution preparation, sample spiking, calculation of results and reporting.

Instrument Interfaces 
To achieve the goals of productivity and GLP confidence, Debra avoids transcription errors by capturing raw data either directly from the instrument or via sample result data files from analytical instrumentation systems. There is no transcription necessary. Seamless communication is provided to and from the instrument software. A wide variety of models and versions of Balances, LSC’s and WBA are handled with instrument specific interfaces.

Security 
Debra has a comprehensive and flexible security structure, which is used to control access to menu items and form-level functions. Given that Debra is used in a regulatory environment, it is important that Debra is able to guard against unauthorised access to studies. Therefore, security is assigned on a user/study basis. System and study-level security roles can be assigned to users to ensure that only those individuals who have the appropriate rights assigned to them can perform their necessary functions.

Quality 
Quality of service and product is of paramount importance to LabLogic and its systems. Our continued efforts in this area have resulted on ISO 9001 accreditation for the design, development and supply of laboratory information management systems, scientific applications software with ongoing maintenance support, including the supply of instrumentation systems for pharmaceutical, agrochemical and contract research organisations.

PK Module 
The PK module further enhances Debra`s capability to go from start to finish on your ADME study. No more transcribing data to additional PK packages, no more `cut-and-paste` to get graphs and data together in your reports. The PK module allows you to view PK data in seconds at any time during or after the study. Transferring the data to a word-processor is just two clicks of the mouse button. Alternatively, data may be seamlessly exported from Debra to industry-standard pharmacokinetic packages such as Pharsight`s WinNonLin™.