The world's leading metabolism Laboratory Information Management system 

Debra is a purpose built LIMS designed specifically to manage the entire life cycle of a range of drug and environmental metabolism studies within a FDA/GLP regulated environment. 

Continuous development over 30 years has resulted in a system that is the industry standard in its field and is used by many of the world's leading Pharmaceutical, Agrochemical and Contract Research Organizations.

Whatever the scope of your study, Debra allows you to take complete control of the process, improving efficiency, whilst meeting the requirements of regulatory compliance at every step.

Improved Efficiency

By managing the data electronically, Debra significantly improves workflow efficiency in the following areas:

  • Direct capture from equipment, thus eliminating transcription errors.
  • Easy to use batch worksheets to organize data capture.
  • Automatic calculations of dosing requirements.
  • Immediate generation of raw data and summary reports.
  • Easy label generation for all samples.
  • Direct links with the industry standard Laura radiochromatography and Seescan WBA software.
  • Automatic calculation of results.
  • Audit Trail.
  • Security Access in accordance with regulatory requirements.
  • Electronic signatures; no more missing manual signatures.

Regulatory Compliance

Debra is a closed system that ensures compliance with regulatory demands.

  • User access is managed via a unique login ID and password that is linked to users’ training and skill set.
  • Electronic signatures and audit trails are fully configurable and in line with the FDA 21 CFR part 11 requirements.
  • Debra has full auditing capabilities to ensure that any changes are fully tracked and easily reportable.

LabLogic have decades of experience creating systems within highly regulated environments. We are confident that our systems will improve compliance within your facility.

Scalable

From single user labs through multi-site global organizations, Debra streamlines processes and workflow with modern intuitive software. Originally designed for simple ADME mass balance and tissue distribution studies, the range and complexity of protocol handled by Debra has been extended covering all aspects of DMPK work including bioanalytical, metabolite profiling and protein binding, as well as environmental fate studies.

Direct Data Capture

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.

  • No transcription necessary.
  • Seamless communication to and from the instrument.
  • A wide variety of models and versions of balances, LSC’s and WBA are handled with
    instrument specific interfaces.
  • Debra Metabolism LIMS 
Previous
Next