LABORATORY EQUIPMENT MANAGEMENT
Product Development Studies play a critical role in gaining a comprehensive understanding of the product and its manufacturing process. Designing studies for Stability Testing, Process Validation or Formulation Optimization can be very complex as they include different interdependent aspects and activities that need to be executed, sometimes over a defined period of time.
BIOVIA Study Design & Tracking provides the tools to efficiently design and manage the multiple study types that are performed in your scientific laboratories, streamlining workflows, reducing cycle times, and providing a comprehensive overview of all existing scientific studies.
STABILITY STUDIES
The goal of a stability study is to determine the extent to which a product, specific formulation, or individual active ingredient stays intact over time and over a range of possible conditions. This provides the basis for expected product shelf life and expiry dates. The regulatory requirement to report the stability of product batches of every unique formulation, dosage strength, and packaging results in both a high volume of work effort and coordination. The effort to design the investigations, track the testing, and generate the necessary reports is significant.
BIOVIA Study Design & Tracking provides data access and monitoring dashboards so responsible parties can see trends and actionable alerts before compliance becomes an issue reducing the risk of citations and fines that may result from failure to demonstrate compliance with specifications.
ON CLOUD OR ON PREMISES
BIOVIA Study Design & Tracking can be deployed on the cloud with the 3DEXPERIENCE® Platform. Cloud deployment minimizes IT overhead and ensures security procedures are carried out by dedicated professional security experts. BIOVIA Study Design & Tracking can also be deployed and validated on-premises if desired. The web-based delivery of BIOVIA Study Design & Tracking simplifies implementation, eliminating the need to install software on every user's computer, while the system’s ability to operate on low bandwidth connections ensures ease of operation anywhere in the world.
BIOVIA STUDY DESIGN & TRACKING CAPABILITIES
- Easy-to-use design and overview of scientific studies
- Integrate selection test criteria and parameters with a centralized library of approved recipes and/or test procedures
- Incorporate multiple dimensions of study parameters, time intervals, and test plans
- Characterize the material by selecting tests and specifications
- Automatically generate a linked Task Plan in BIOVIA Unified Lab
- Get a graphical overview of the progress of the Study over the lifetime of the investigation
- Create specific reports configuring included standard reports
Benefits
- Easily design and manage studies across R&D minimizing the effort of defining independent study arm
- Improve visibility of the experimental design/development process to the organization
- Track and trace all data and author activities of your scientific studies
- Get better insight into current operations
- Improve consistency of study design implementations globally
- Control your study design approval workflow with appropriate management and electronic signatures
