Development Log API

Development Log API provides a structure and a context for documents and information for users
working on API process development activities or users who need to draw information from those
activities. The application allows a user to collect data, create process description, record batch
data, and organize it into interactive data display screens and reports. It can be the single
repository where 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 API 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.
• Impurities Library – record impurity structures and information.
• Synthetic Route Library – store multiple development synthetic routes in the application.
• Vendor Library – record supplier and raw material information
• Reports – User definable reports allow user to query actual batch results and organize into
  interactive reports.
• Role-based Security – defines which users have access and to what information across your
  organization.
• Audit Tracking – records time stamp and offers audit trail of data entry

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 process development and
  batch records.
• Reports –Rondaxe reports can be used to support process development, annual updates and
  regulatory activities.
• Due Diligence Activities – outstanding tool in an electronic data room for due diligence examinations