Development Log Formulations Overview
Development Log Formulations provides a structure and a context for documents and information for users working on drug product process development activities or users who need to draw information from those activities. The application allows a user to collect data, create process, process flow diagrams, record actual batch data, and organize it into interactive data display screens and reports. It can be the single repository where development data can be stored and managed in an intelligent way and where users can dynamically interact with data in new ways, for example, organizing the experimental program for product development. The Development Log Formulations can also be used to maintain the project status, history and milestones. In addition, the application can be used to support regulatory filings and annual updates.
Key Features
- Fully relational database – records and relates data associated with individual programs or
active ingredients - Stores structured and unstructured data including documents and JPEG images
- Scalability – easily supports large and small enterprises
- Intuitive user interface to easily input and mine drug development data and provide unique
reports. - Graphical User Interface to Build Processes – Unit Operations Library includes list and icons
for standard unit operations - Drug Product Stability Library – record stability program information, conditions and results.
- Role-based Security – defines which users have access and to what information across your
organization. - Drug Product Process Flow Diagrams – intuitive interface to build flow diagrams.
- Calculation of Formula Based on Actual Inputs – calculates formula composition based on
input material quantities. - Mass Balance Functionality – allows calculation of mass balance in process.
- Batch Specifications & Results Handling – store specifications and results.
- Batch Comparison – comparison of batches and formula information
Key Benefits
- Share information across the organization – information can be accessed and organized by
steps in the development process, functional group (manufacturing, finance, supply chain,
etc.), or type of records (batch, analytics, etc.) - Data Entry –The application interface offers easy ways to enter individual or multiple data
records. For organizations that historically have only maintained their data on paper
or in electronic documents, entering data in the Development Log may be a barrier. - Process Flow Diagrams – easily build and print process flow diagrams
- Reports –Rondaxe reports can be used to support drug pvrocess development/regulatory
activities