LIMS E-Notebook
E-Notebook provides a smooth, well-organized interface designed to replace paper laboratory notebooks. With E-notebook, users can easily insert content from Word, Excel, PowerPoint, Acrobat PDF, ChemDraw and structured data in lists and tables. Forms are configured with any combination of these. Oracle or SQL support allows organizations to share data, as well as maintain rigorous security and efficient archiving. With E-Notebook, users get the flexibility of a shared drive with the compliance and search benefits of an Oracle database.
E-Notebook has been developed over the last 10 years in close collaboration with many of the world’s top research and development organizations. This development has been facilitated by detailed interactions with leading compliance and intellectual property experts as well as some of the best system architects in R&D. If your organization wants an enterprise electronic laboratory solution, you need look no further.
Formulation and Validation
E-Notebook's formulation module is designed to support the dual workflows and regulatory compliance needs of formulation engineers. The flexibility allows any number of formulations to be created, and security allows only designated administrators to create a new formulation.
Analytical & Quality Control
Analytical and Quality Control Laboratories must execute defined procedures to test material that may be administered during preclinical and clinical trials. This work must also be compliant with both GxP and 21 CFR Part 11. Templates for standard analytical tests are provided and analytical procedures are implemented as E-Notebook forms, which are easily designed and controlled. Equally important, E-Notebook provides workflow enforcement that monitors data entry and ensures that the forms are completed in sequence for proper method execution.
For example, rules can be configured such that the 'Day 3' form of a multi-day process will not accept any entries unless all required fields on the 'Day 2' form are first completed. The forms can contain automatic calculations to compute totals, averages, differences, and much more. E-Notebook can further streamline the procedure by allowing for electronic management of solutions, equipment, and other resources that are needed for experiments.
Drug Metabolism
E-Notebook supports the DMPK laboratories in testing the metabolism and longevity of compounds in various in vitro and in vivo models. DMPK data capture needs can vary significantly, and the flexibility of the E-Notebook solution addresses this. For example, an in vivo enzyme induction test may create relatively small amounts of data for which scientists utilize E-Notebook integration with Microsoft Excel. Conversely, large quantities of data, such as those generated by in vitro enzyme inhibition studies, are often collected and analyzed by applications such as BioAssay. Therefore, integration with BioAssay and Excel are fundamental to DMPK E-Notebook usage.
Pharmacokinetics (DMPK)
There is a holistic approach to Drug Metabolism and Pharmacokinetics. No single study describes the behavior of a compound; it is the combination of data from disparate experiments that represents the pharmacological profile for a compound. It is here where E-Notebook reveals one of its most significant capabilities: the reporting feature. E-Notebook reports are flexible: any field (e.g. compound ID, study type, etc.) can be used to query the system and any field (e.g. conclusion, dose, etc.) or field aggregate (e.g. average radioactivity) can be displayed in the report. Reports are dynamic and navigable: results are displayed with links that provide quick access to experiments.
Reports are viewed directly in the E-Notebook interface, but they can also be exported to Microsoft Word or PDF to share with those who do not have E-Notebook access.
