Laboratory Infrastructure

DiTEBA occupies 9,000 square feet of fully network-equipped, state-of-the-art laboratory and office space, including a stability storage room with temperature and humidity chambers covering entire ICH recommended range of storage.

Laboratory Instrument Data

All laboratory instrument data is captured and processed by Empower® Chromatography Data Software. Empower Software addresses sponsor's concerns via data security, compliance and validation and allows us to maximize productivity of laboratory instrumentation.

Data Capturing, Processing and Archiving

The core building block of our data infrastructure is the web-based Waters NuGenesis® Scientific Data Management System (SDMS) platform, providing us with the foundation for data preservation and integrating flow of information throughout the organization. NuGenesis® SDMS provides our sponsors with a fully electronic audit trail and an enhanced data security environment.  Instant web-access to test results brings an additional layer of security and cost efficiency to our sponsors.

Stability Room Monitoring System

All our temperature and humidity stability chambers are monitored by the CENTRON Monitoring System® by Rees Scientific Corporation.  This provides our sponsors with electronic information about the test environment in compliance with FDA 21 CFR 11, cGMP and GLP regulations.