CentraDATA software provides comprehensive data and document management
for the pharmaceutical manufacturing process. When dealing with mountains of data
the CentraDATA software can provide context and structure, which is key to
improving the challenging task of bringing a drug to market.
CentraDATA software provides comprehensive data and document management for the pharmaceutical manufacturing process.
Key Features
- Create and maintain data on multiple projects
- Tracks and retrieves active pharmaceutical ingredients (API)
- Tracks and retrieves drug product formulations
- Link to legacy document management systems
- Manage and link internal documents
- Manage all bill of materials (BOM) data
- Manage batch information and results
- Build custom libraries of materials and vendors
- Links manufacturing data including process parameters, IPC results, stability data, release test results and yields
- Visual diagrams for synthetic routes and drug product process flow
- Equipment options
- Stability studies
- Import from extensive proprietary library of materials and mendors
- Supports development and regulatory filing work
- Produce custom analytics for a range of data
Who Benefits
CentraDATA is a centralized data access point
- Improves efficiency by simplifying organization
- Creates a standardized, company-wide collaboration system
- Serves as a single, intuitive gateway
- Performs functionally connected but often logistically disparate tasks
- Provides links to legacy document systems, for easy tracking of vital data & documents
- Contextualizes supplementary info that allows for the management of multiple projects
- Expedites identification of immediate and mid-range needs
CentraDATA is due diligence made simple
- Expedites data tracking and easy identification of potential data deficiencies
- Provides a centralized system makes all relevant data accessible via one interface
- Allows managers to easily extract relevant information for filings
- Creates a common platform allowing teams of differing specialties to work together more cohesively
CentraDATA offers cost savings
- Maximizes employee efficiency and reduces consultant expenditures
- Enhances tracking capabilities to pinpoint possible defects in the case of a Compliant or Adverse Drug Event (ADE)
- Simple, seamless data transfer afforded by the software leads to more efficient and reliable regulatory protocols, including
- FDA preparation
- Annual updates
- IND
- NDA
- Filings
- Milestone accountability
